About Us Visa is a world leader in payments technology, facilitating transactions between consumers, merchants, financial institutions and government entities across more than 200 countries and territories, dedicated to uplifting everyone, everywhere by being the best way to pay and be paid. At Visa, you'll have the opportunity to create impact at scale - tackling meaningful challenges, growing your skills and seeing your contributions impact lives around the world. Join Visa and do work that matters - to you, to your community, and to the world. Progress starts with you. Job Description Visa's Technology Organization is a community of problem solvers and innovators reshaping the future of commerce. We operate the world's most sophisticated processing networks capable of handling more than 65k secure transactions a second across 80M merchants, 15k Financial Institutions, and billions of everyday people. While working with us you'll get to work on complex distributed systems and solve massive scale problems centered on new payment flows, business and data solutions, cyber security, and B2C platforms. The Opportunity: We are looking for Versatile, curious, and energetic Software Engineers who embrace solving complex challenges on a global scale. As a Visa Software Engineer, you will be an integral part of a multi-functional development team inventing, designing, building, and testing software products that reach a truly global customer base. Join the Commercial and Money Movement Solutions (CMS) organization as a Senior Staff Engineer focused on leveraging AI to solve complex engineering and customer challenges. You will work on innovative solutions that combine deep technical expertise with AI/ML capabilities to enhance developer productivity, improve customer experiences, and drive next-generation commercial payment and money movement technology for B2B, B2C, P2P, and G2C flows. The Work itself: Design and architect AI-powered solutions that solve engineering productivity challenges and enhance customer-facing products across CMS Lead technical initiatives leveraging agentic AI, LLMs, and machine learning to automate workflows and improve software quality Collaborate multi-functionally to create design artifacts and develop best-in-class software solutions for multiple Visa technical offerings Drive experimentation with emerging AI technologies and make technical decisions on adoption and standards Develop robust and scalable products intended for a myriad of customers including end-user merchants, b2b, and business to government solutions. Develop scalable platforms and services that integrate AI capabilities into Visa's commercial payment and money movement systems Opportunities to make a difference on a global or local scale through mentorship and continued learning opportunities Essential Functions: Works directly with product owners to gather and refine requirements across products, adding and taking into account existing tools and solutions across the organization. Develops and designs advanced architect solutions that are robust and scalable, integrating AI capabilities with Visa's technical ecosystem Provides domain expertise on the development of technical documentation of solutions and contributes to standard processes in technical documentation as needed. Plays a key role in the development and delivery of new features across products from end-to-end. This is a hybrid position. Expectation of days in the office will be confirmed by your Hiring Manager. Visa requires at least 3 days in office, expectations of these days will be confirmed by your Hiring Manager. Qualifications Basic Qualifications • 8+ years of relevant work experience with a Bachelor's Degree or at least 5 years of experience with an Advanced Degree (e.g. Masters, MBA, JD, MD) or 2 years of work experience with a PhD, OR 11+ years of relevant work experience. Preferred Qualifications • 9 or more years of relevant work experience with a Bachelor Degree or 7 or more relevant years of experience with an Advanced Degree (e.g. Masters, MBA, JD, MD) or 3 or more years of experience with a PhD • Master's degree in Math, Science, Engineering, Computer Science, Information Systems or related field AND minimum six (6) years of experience in a directly related field OR Bachelor's degree in Math, Science, Engineering, Computer Science, Information Systems or related field AND minimum eight (8) years of experience in a directly related field OR Minimum eleven (11) years of directly related experience • Experience with AI agent frameworks, LLMs, or generative AI applications (Claude, GPT, etc.) • Knowledge of AI-powered development tools (Claude Code, GitHub Copilot, etc.) or building similar systems • Experience applying AI to solve engineering challenges or customer-facing product features • Understanding of commercial payments, money movement, B2B payables, or payment processing • Experience with cloud platforms (AWS, Azure, GCP) and modern architectures • Knowledge of API design, microservices, and distributed systems • Experience leading cross-team technical initiatives The Skills You Bring • Energy and Experience: A growth mindset that is curious and passionate about technologies and enjoys challenging projects on a global scale • AI Expertise: Experience with agentic AI, LLMs, AI agent frameworks, or machine learning applications • Challenge the Status Quo: Comfort in pushing the boundaries, 'hacking' beyond traditional solutions • Language Expertise: Expertise in one or more general development languages (e.g., Java, C#, C++) • Architecture & Design: Proven track record designing scalable systems that integrate AI capabilities • Builder: Experience building AI-powered features for engineering productivity or customer-facing applications • Learner: Constant drive to learn new technologies such as Angular, React, Kubernetes, Docker, etc. • Partnership: Experience collaborating with Product, Test, Dev-ops, and Agile/Scrum teams • We do not expect that any single candidate would fulfill all of these characteristics. For instance, we have exciting team members who are really focused on building scalable systems but didn't work with payments technology or web applications before joining Visa. Information for US Applicants For roles located in the US, the estimated salary range for this position is $169,100.00 to $ 270,800.00 USD per year, which may include potential sales incentive payments (if applicable). Salary may vary depending on job-related factors which may include knowledge, skills, experience, and location. In addition, this position may be eligible for bonus and equity.Visa has a comprehensive benefits package for which this position may be eligible that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness Program. Work Hours Varies upon the needs of the department. Travel Requirements This position requires travel 5-10% of the time. Mental/Physical Requirements This position will be performed in an office setting. The position will require the incumbent to sit and stand at a desk, communicate in person and by telephone, frequently operate standard office equipment, such as telephones and computers. Visa is an EEO Employer Qualified applicants will receive consideration for employment without regard to race, color religion, sex, national origin, sexual orientation, gender identity, disability or protect veteran status. Visa will also consider for employment qualified applicants with criminal histories in a manner consistent with the EEOC guidelines and applicable local law.
09/25/2026
Full time
About Us Visa is a world leader in payments technology, facilitating transactions between consumers, merchants, financial institutions and government entities across more than 200 countries and territories, dedicated to uplifting everyone, everywhere by being the best way to pay and be paid. At Visa, you'll have the opportunity to create impact at scale - tackling meaningful challenges, growing your skills and seeing your contributions impact lives around the world. Join Visa and do work that matters - to you, to your community, and to the world. Progress starts with you. Job Description Visa's Technology Organization is a community of problem solvers and innovators reshaping the future of commerce. We operate the world's most sophisticated processing networks capable of handling more than 65k secure transactions a second across 80M merchants, 15k Financial Institutions, and billions of everyday people. While working with us you'll get to work on complex distributed systems and solve massive scale problems centered on new payment flows, business and data solutions, cyber security, and B2C platforms. The Opportunity: We are looking for Versatile, curious, and energetic Software Engineers who embrace solving complex challenges on a global scale. As a Visa Software Engineer, you will be an integral part of a multi-functional development team inventing, designing, building, and testing software products that reach a truly global customer base. Join the Commercial and Money Movement Solutions (CMS) organization as a Senior Staff Engineer focused on leveraging AI to solve complex engineering and customer challenges. You will work on innovative solutions that combine deep technical expertise with AI/ML capabilities to enhance developer productivity, improve customer experiences, and drive next-generation commercial payment and money movement technology for B2B, B2C, P2P, and G2C flows. The Work itself: Design and architect AI-powered solutions that solve engineering productivity challenges and enhance customer-facing products across CMS Lead technical initiatives leveraging agentic AI, LLMs, and machine learning to automate workflows and improve software quality Collaborate multi-functionally to create design artifacts and develop best-in-class software solutions for multiple Visa technical offerings Drive experimentation with emerging AI technologies and make technical decisions on adoption and standards Develop robust and scalable products intended for a myriad of customers including end-user merchants, b2b, and business to government solutions. Develop scalable platforms and services that integrate AI capabilities into Visa's commercial payment and money movement systems Opportunities to make a difference on a global or local scale through mentorship and continued learning opportunities Essential Functions: Works directly with product owners to gather and refine requirements across products, adding and taking into account existing tools and solutions across the organization. Develops and designs advanced architect solutions that are robust and scalable, integrating AI capabilities with Visa's technical ecosystem Provides domain expertise on the development of technical documentation of solutions and contributes to standard processes in technical documentation as needed. Plays a key role in the development and delivery of new features across products from end-to-end. This is a hybrid position. Expectation of days in the office will be confirmed by your Hiring Manager. Visa requires at least 3 days in office, expectations of these days will be confirmed by your Hiring Manager. Qualifications Basic Qualifications • 8+ years of relevant work experience with a Bachelor's Degree or at least 5 years of experience with an Advanced Degree (e.g. Masters, MBA, JD, MD) or 2 years of work experience with a PhD, OR 11+ years of relevant work experience. Preferred Qualifications • 9 or more years of relevant work experience with a Bachelor Degree or 7 or more relevant years of experience with an Advanced Degree (e.g. Masters, MBA, JD, MD) or 3 or more years of experience with a PhD • Master's degree in Math, Science, Engineering, Computer Science, Information Systems or related field AND minimum six (6) years of experience in a directly related field OR Bachelor's degree in Math, Science, Engineering, Computer Science, Information Systems or related field AND minimum eight (8) years of experience in a directly related field OR Minimum eleven (11) years of directly related experience • Experience with AI agent frameworks, LLMs, or generative AI applications (Claude, GPT, etc.) • Knowledge of AI-powered development tools (Claude Code, GitHub Copilot, etc.) or building similar systems • Experience applying AI to solve engineering challenges or customer-facing product features • Understanding of commercial payments, money movement, B2B payables, or payment processing • Experience with cloud platforms (AWS, Azure, GCP) and modern architectures • Knowledge of API design, microservices, and distributed systems • Experience leading cross-team technical initiatives The Skills You Bring • Energy and Experience: A growth mindset that is curious and passionate about technologies and enjoys challenging projects on a global scale • AI Expertise: Experience with agentic AI, LLMs, AI agent frameworks, or machine learning applications • Challenge the Status Quo: Comfort in pushing the boundaries, 'hacking' beyond traditional solutions • Language Expertise: Expertise in one or more general development languages (e.g., Java, C#, C++) • Architecture & Design: Proven track record designing scalable systems that integrate AI capabilities • Builder: Experience building AI-powered features for engineering productivity or customer-facing applications • Learner: Constant drive to learn new technologies such as Angular, React, Kubernetes, Docker, etc. • Partnership: Experience collaborating with Product, Test, Dev-ops, and Agile/Scrum teams • We do not expect that any single candidate would fulfill all of these characteristics. For instance, we have exciting team members who are really focused on building scalable systems but didn't work with payments technology or web applications before joining Visa. Information for US Applicants For roles located in the US, the estimated salary range for this position is $169,100.00 to $ 270,800.00 USD per year, which may include potential sales incentive payments (if applicable). Salary may vary depending on job-related factors which may include knowledge, skills, experience, and location. In addition, this position may be eligible for bonus and equity.Visa has a comprehensive benefits package for which this position may be eligible that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness Program. Work Hours Varies upon the needs of the department. Travel Requirements This position requires travel 5-10% of the time. Mental/Physical Requirements This position will be performed in an office setting. The position will require the incumbent to sit and stand at a desk, communicate in person and by telephone, frequently operate standard office equipment, such as telephones and computers. Visa is an EEO Employer Qualified applicants will receive consideration for employment without regard to race, color religion, sex, national origin, sexual orientation, gender identity, disability or protect veteran status. Visa will also consider for employment qualified applicants with criminal histories in a manner consistent with the EEOC guidelines and applicable local law.
Job DescriptionJob Description Location: Waltham, MA & Framingham, MA This role will require full-time on-site presence at our client site in Framingham or Waltham. MA. This role is NOT eligible for relocation assistance The Zifo Lab Computing Analyst provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal Zifo support team. Requirements Required Skills: Excellent customer service skills complemented by an ability to listen to and interpret client requests Ability to troubleshoot complex instrument and technology issues Strong oral and written communication skills Ability to identify, track and complete tasks for multiple projects Knowledge of laboratory safety practices as defined by the company and/or customer's site safety code Responsibilities: As a Lab Computing Analyst, beneficiary would perform following key responsibilities: Requirements Management and onsite Validation/Compliance support IT Consulting Customer Liaison Onsite Lab IT Support Requirements Management Understand problem statement/challenges Define scope Gather requirements. Assist with Validation/Compliance activities (IOPQ) as required. Analyze current state business processes and requirements. Assist in building plans for process improvement IT Consulting Analyze gaps/opportunities for improvement based on industry Best Practice Evaluate Industry trends to identify areas for optimization Evaluate vendor solutions and facilitate demos of prototypes as Proofs of Concept Recommend process improvements that fit business needs Customer Liaison: Meeting with internal/external service groups/leads Liaise between System/Lab owners and third parties to coordinate best times for services Provide weekly planning schedules for review at status meeting with customer leads Monthly Operational review meetings/ Quarterly metrics reporting with department heads On Site Lab IT Support: Perform break/fix support for all Instrument connected systems Implement Windows based security policies as required Ensure adherence to client's corporate policies through periodic reporting & compliance programs Acts as the technical support contact for field service engineers and external vendors Provide technical subject matter expertise for new system validation and change management Create and maintain a physical inventory of lab equipment, PC's, software, and any other information pertinent to the environment if applicable Perform system preventative maintenances based on client's schedule, if applicable Requirements Bachelor's/Master's degree or equivalent in Pharmaceutical, Bio-technology, Bio-medical, Chemical 3+ years of relevant technical experience including (but not limited to); Windows technologies, networking, remote computing and backup systems At least 1 year in software development and testing. At least 1 year of experience in business requirement analysis and gathering. Demonstrated domain area knowledge. Candidate must possess excellent analytical and interpersonal skills along with a proven track record in system design, implementation, have demonstrated ability to guide the activities of colleagues, and have demonstrated ability to gain client's confidence and trust. Candidate must demonstrate in-depth understanding in one or more of the following areas of Bio/Pharma industry: Drug Discovery & Development Processes Clinical study planning & Data management Lab Workflows Chemical & Biologics material Management Sample Management Robotic Systems Integration & Qualification Operations KPI and Metrics tracking Optional requirement: Candidate needs to be familiar with the US and International Regulations and Standards governing the development of technical solutions such as GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820 Technical Skills: Operating System familiarity with at least 1 of the following: Unix, Windows, MVS Software Methodology familiarity with: Object Oriented Programming, Structured Programming Software Development Process familiarity with: Waterfall, Agile Change Control Management and Risk Management Office Tools proficiency required in : MS Word, Excel, PowerPoint Office productivity tool proficiency in at least 1 of the following: Visio, MS Project, SharePoint Benefits About Zifo: CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team's knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies. We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a "no doors" policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda - technical competency and cultural adaptability. We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts. If you share these sentiments and are prepared for the atypical, then Zifo is your calling! Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
09/25/2026
Full time
Job DescriptionJob Description Location: Waltham, MA & Framingham, MA This role will require full-time on-site presence at our client site in Framingham or Waltham. MA. This role is NOT eligible for relocation assistance The Zifo Lab Computing Analyst provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal Zifo support team. Requirements Required Skills: Excellent customer service skills complemented by an ability to listen to and interpret client requests Ability to troubleshoot complex instrument and technology issues Strong oral and written communication skills Ability to identify, track and complete tasks for multiple projects Knowledge of laboratory safety practices as defined by the company and/or customer's site safety code Responsibilities: As a Lab Computing Analyst, beneficiary would perform following key responsibilities: Requirements Management and onsite Validation/Compliance support IT Consulting Customer Liaison Onsite Lab IT Support Requirements Management Understand problem statement/challenges Define scope Gather requirements. Assist with Validation/Compliance activities (IOPQ) as required. Analyze current state business processes and requirements. Assist in building plans for process improvement IT Consulting Analyze gaps/opportunities for improvement based on industry Best Practice Evaluate Industry trends to identify areas for optimization Evaluate vendor solutions and facilitate demos of prototypes as Proofs of Concept Recommend process improvements that fit business needs Customer Liaison: Meeting with internal/external service groups/leads Liaise between System/Lab owners and third parties to coordinate best times for services Provide weekly planning schedules for review at status meeting with customer leads Monthly Operational review meetings/ Quarterly metrics reporting with department heads On Site Lab IT Support: Perform break/fix support for all Instrument connected systems Implement Windows based security policies as required Ensure adherence to client's corporate policies through periodic reporting & compliance programs Acts as the technical support contact for field service engineers and external vendors Provide technical subject matter expertise for new system validation and change management Create and maintain a physical inventory of lab equipment, PC's, software, and any other information pertinent to the environment if applicable Perform system preventative maintenances based on client's schedule, if applicable Requirements Bachelor's/Master's degree or equivalent in Pharmaceutical, Bio-technology, Bio-medical, Chemical 3+ years of relevant technical experience including (but not limited to); Windows technologies, networking, remote computing and backup systems At least 1 year in software development and testing. At least 1 year of experience in business requirement analysis and gathering. Demonstrated domain area knowledge. Candidate must possess excellent analytical and interpersonal skills along with a proven track record in system design, implementation, have demonstrated ability to guide the activities of colleagues, and have demonstrated ability to gain client's confidence and trust. Candidate must demonstrate in-depth understanding in one or more of the following areas of Bio/Pharma industry: Drug Discovery & Development Processes Clinical study planning & Data management Lab Workflows Chemical & Biologics material Management Sample Management Robotic Systems Integration & Qualification Operations KPI and Metrics tracking Optional requirement: Candidate needs to be familiar with the US and International Regulations and Standards governing the development of technical solutions such as GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820 Technical Skills: Operating System familiarity with at least 1 of the following: Unix, Windows, MVS Software Methodology familiarity with: Object Oriented Programming, Structured Programming Software Development Process familiarity with: Waterfall, Agile Change Control Management and Risk Management Office Tools proficiency required in : MS Word, Excel, PowerPoint Office productivity tool proficiency in at least 1 of the following: Visio, MS Project, SharePoint Benefits About Zifo: CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team's knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies. We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a "no doors" policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda - technical competency and cultural adaptability. We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts. If you share these sentiments and are prepared for the atypical, then Zifo is your calling! Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Job DescriptionJob Description Location: Waltham, MA & Framingham, MA This role will require full-time on-site presence at our client site in Framingham or Waltham. MA. This role is NOT eligible for relocation assistance The Zifo Lab Computing Analyst provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal Zifo support team. Requirements Required Skills: Excellent customer service skills complemented by an ability to listen to and interpret client requests Ability to troubleshoot complex instrument and technology issues Strong oral and written communication skills Ability to identify, track and complete tasks for multiple projects Knowledge of laboratory safety practices as defined by the company and/or customer's site safety code Responsibilities: As a Lab Computing Analyst, beneficiary would perform following key responsibilities: Requirements Management and onsite Validation/Compliance support IT Consulting Customer Liaison Onsite Lab IT Support Requirements Management Understand problem statement/challenges Define scope Gather requirements. Assist with Validation/Compliance activities (IOPQ) as required. Analyze current state business processes and requirements. Assist in building plans for process improvement IT Consulting Analyze gaps/opportunities for improvement based on industry Best Practice Evaluate Industry trends to identify areas for optimization Evaluate vendor solutions and facilitate demos of prototypes as Proofs of Concept Recommend process improvements that fit business needs Customer Liaison: Meeting with internal/external service groups/leads Liaise between System/Lab owners and third parties to coordinate best times for services Provide weekly planning schedules for review at status meeting with customer leads Monthly Operational review meetings/ Quarterly metrics reporting with department heads On Site Lab IT Support: Perform break/fix support for all Instrument connected systems Implement Windows based security policies as required Ensure adherence to client's corporate policies through periodic reporting & compliance programs Acts as the technical support contact for field service engineers and external vendors Provide technical subject matter expertise for new system validation and change management Create and maintain a physical inventory of lab equipment, PC's, software, and any other information pertinent to the environment if applicable Perform system preventative maintenances based on client's schedule, if applicable Requirements Bachelor's/Master's degree or equivalent in Pharmaceutical, Bio-technology, Bio-medical, Chemical 3+ years of relevant technical experience including (but not limited to); Windows technologies, networking, remote computing and backup systems At least 1 year in software development and testing. At least 1 year of experience in business requirement analysis and gathering. Demonstrated domain area knowledge. Candidate must possess excellent analytical and interpersonal skills along with a proven track record in system design, implementation, have demonstrated ability to guide the activities of colleagues, and have demonstrated ability to gain client's confidence and trust. Candidate must demonstrate in-depth understanding in one or more of the following areas of Bio/Pharma industry: Drug Discovery & Development Processes Clinical study planning & Data management Lab Workflows Chemical & Biologics material Management Sample Management Robotic Systems Integration & Qualification Operations KPI and Metrics tracking Optional requirement: Candidate needs to be familiar with the US and International Regulations and Standards governing the development of technical solutions such as GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820 Technical Skills: Operating System familiarity with at least 1 of the following: Unix, Windows, MVS Software Methodology familiarity with: Object Oriented Programming, Structured Programming Software Development Process familiarity with: Waterfall, Agile Change Control Management and Risk Management Office Tools proficiency required in : MS Word, Excel, PowerPoint Office productivity tool proficiency in at least 1 of the following: Visio, MS Project, SharePoint Benefits About Zifo: CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team's knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies. We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a "no doors" policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda - technical competency and cultural adaptability. We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts. If you share these sentiments and are prepared for the atypical, then Zifo is your calling! Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
09/25/2026
Full time
Job DescriptionJob Description Location: Waltham, MA & Framingham, MA This role will require full-time on-site presence at our client site in Framingham or Waltham. MA. This role is NOT eligible for relocation assistance The Zifo Lab Computing Analyst provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal Zifo support team. Requirements Required Skills: Excellent customer service skills complemented by an ability to listen to and interpret client requests Ability to troubleshoot complex instrument and technology issues Strong oral and written communication skills Ability to identify, track and complete tasks for multiple projects Knowledge of laboratory safety practices as defined by the company and/or customer's site safety code Responsibilities: As a Lab Computing Analyst, beneficiary would perform following key responsibilities: Requirements Management and onsite Validation/Compliance support IT Consulting Customer Liaison Onsite Lab IT Support Requirements Management Understand problem statement/challenges Define scope Gather requirements. Assist with Validation/Compliance activities (IOPQ) as required. Analyze current state business processes and requirements. Assist in building plans for process improvement IT Consulting Analyze gaps/opportunities for improvement based on industry Best Practice Evaluate Industry trends to identify areas for optimization Evaluate vendor solutions and facilitate demos of prototypes as Proofs of Concept Recommend process improvements that fit business needs Customer Liaison: Meeting with internal/external service groups/leads Liaise between System/Lab owners and third parties to coordinate best times for services Provide weekly planning schedules for review at status meeting with customer leads Monthly Operational review meetings/ Quarterly metrics reporting with department heads On Site Lab IT Support: Perform break/fix support for all Instrument connected systems Implement Windows based security policies as required Ensure adherence to client's corporate policies through periodic reporting & compliance programs Acts as the technical support contact for field service engineers and external vendors Provide technical subject matter expertise for new system validation and change management Create and maintain a physical inventory of lab equipment, PC's, software, and any other information pertinent to the environment if applicable Perform system preventative maintenances based on client's schedule, if applicable Requirements Bachelor's/Master's degree or equivalent in Pharmaceutical, Bio-technology, Bio-medical, Chemical 3+ years of relevant technical experience including (but not limited to); Windows technologies, networking, remote computing and backup systems At least 1 year in software development and testing. At least 1 year of experience in business requirement analysis and gathering. Demonstrated domain area knowledge. Candidate must possess excellent analytical and interpersonal skills along with a proven track record in system design, implementation, have demonstrated ability to guide the activities of colleagues, and have demonstrated ability to gain client's confidence and trust. Candidate must demonstrate in-depth understanding in one or more of the following areas of Bio/Pharma industry: Drug Discovery & Development Processes Clinical study planning & Data management Lab Workflows Chemical & Biologics material Management Sample Management Robotic Systems Integration & Qualification Operations KPI and Metrics tracking Optional requirement: Candidate needs to be familiar with the US and International Regulations and Standards governing the development of technical solutions such as GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820 Technical Skills: Operating System familiarity with at least 1 of the following: Unix, Windows, MVS Software Methodology familiarity with: Object Oriented Programming, Structured Programming Software Development Process familiarity with: Waterfall, Agile Change Control Management and Risk Management Office Tools proficiency required in : MS Word, Excel, PowerPoint Office productivity tool proficiency in at least 1 of the following: Visio, MS Project, SharePoint Benefits About Zifo: CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team's knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies. We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a "no doors" policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda - technical competency and cultural adaptability. We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts. If you share these sentiments and are prepared for the atypical, then Zifo is your calling! Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Job DescriptionJob Description At AmaWaterways, we believe meaningful careers begin with purpose, passion and a shared commitment to delivering unforgettable experiences. For those who value curiosity, connection and personal enrichment, AmaWaterways offers the opportunity to help craft meaningful river journeys that invite travelers to follow their own current. Built on a foundation of heartfelt hospitality, we treat our guests-and each other-with genuine care, warmth and respect. AmaWaterways fosters a collaborative environment both onboard our ships and across our global network of offices, where team members grow together, support one another and take pride in upholding the high standards and thoughtful service our company is known for. We invite talented, motivated professionals to explore our career opportunities and begin their journey with AmaWaterways today. This position is primarily responsible for leading and growing the quality assurance function across the company's web platform, APIs, integrations, and supporting services. The QA Manager owns the overall QA strategy, standards, and processes; manages and develops the QA team; and partners with engineering, product, and DevOps to ensure releases are predictable, reliable, and delivered with confidence. DUTIES AND RESPONSIBILITIES: Defines, owns, and continuously improves the end-to-end QA strategy across web, mobile-web, backend services, and integrations. Leads, mentors, and grows a team of QA specialists, automation engineers, and SDETs, fostering a culture of quality and accountability. Establishes and maintains QA standards, test plans, regression suites, smoke-test procedures, and release sign-off processes. Champions shift-left testing and embeds quality practices across the engineering organization. Identifies critical user journeys and high-risk areas, ensuring appropriate test coverage at each layer of the test pyramid. Sets the direction for automation frameworks across UI, API, and integration testing, and ensures suites are robust, maintainable, and trusted. Oversees integration of automated tests into CI/CD pipelines, and defines quality gates, deployment criteria, and rollback triggers in collaboration with DevOps. Owns release readiness and sign-off, ensuring consistent, repeatable, and low-risk deployments across Dev, QA, UAT, and Production. Defines, tracks, and reports on key quality metrics such as defect leakage, escape rate, test coverage, flakiness, MTTD, and MTTR. Provides clear, regular quality reporting and risk assessments to engineering leadership and business stakeholders. Manages relationships with external QA vendors and tooling providers, and contributes to build-versus-buy decisions. Analyzes production incidents to identify gaps in coverage and process, and drives corrective and preventive actions. Establishes and maintains quality governance, including audit readiness, compliance, and data-handling considerations relevant to the business. Evaluates and introduces new tools, technologies, and methodologies to advance the QA function. Provides project effort estimations and resource planning for QA activities across competing priorities. Communicates effectively with technical and non-technical groups, both internally and externally. Maintains current knowledge of relevant technology and quality engineering practices, as assigned. Participates in special projects, as required. Performs other related duties as assigned by management. SUPERVISORY RESPONSIBILITIES: This job carries out supervisory responsibilities in accordance with the organization's policies and applicable laws: Provides day-to-day leadership, mentorship, and technical direction to QA team members. Leads interviewing, evaluation, and hiring of QA specialists, automation engineers, and SDETs. Owns onboarding and training to ensure adherence to quality standards and best practices. Assigns work, monitors progress, and ensures timely delivery of testing and release activities. Conducts performance discussions, sets goals, and supports the professional development of team members. Manages capacity and resource allocation across projects, releases, and competing priorities. Addresses workplace or project-related concerns and escalates issues when appropriate. QUALIFICATIONS: Bachelor's Degree (BA/BS) from a four-year college or university, or seven or more years of related experience and/or training, or an equivalent combination of education and experience. Seven or more years of professional QA experience, with at least three years in a lead or management capacity. Proven track record of building, leading, and scaling QA teams and functions. Computer skills required: Microsoft Office Suite; Project Management Software; Test Management and Defect Tracking Software (e.g., Jira); Database Software; Development Software; Internet Software; Spreadsheet Software; Word Processing Software; Electronic Mail Software; Presentation Software. Other skills required: Strong technical foundation in test automation, with hands-on experience in UI automation (Playwright, Cypress, or Selenium) and API testing tools (Postman/Newman, REST Assured, or Pact). Experience defining QA strategy and embedding quality practices across engineering organizations. Solid understanding of CI/CD pipelines and integrating automated testing into delivery workflows (Azure DevOps, GitHub Actions, Jenkins, or similar). Strong grasp of testing methodologies: TDD, BDD, the test pyramid, risk-based testing, and exploratory testing. Solid understanding of REST APIs, HTTP, authentication mechanisms (OAuth, JWT), and API contract testing. Experience with version control (Git) and code review practices. Strong experience with relational databases and writing SQL queries for data validation and analysis. Demonstrated people-management skills: hiring, mentoring, performance management, and resource planning. Cloud, DevOps, and CI/CD: Familiarity with cloud platforms (preferably Microsoft Azure), including app hosting, storage, networking, and security concepts. Experience embedding automated build, test, and deployment quality gates across multiple environments (Dev, QA, UAT, Prod). Experience with application monitoring, logging, and alerting in cloud environments (e.g., Datadog, New Relic, Grafana, Sentry). Performance and load testing experience with k6, JMeter, or Gatling is a plus. Security Methodology: Knowledge of secure coding and application security principles (e.g., OWASP Top 10) and security testing fundamentals. Experience working in Agile/Scrum environments; Scrum Master experience is a plus. ISTQB Advanced Level certification, or other relevant quality/leadership certification, is a plus. Experience managing QA in travel, hospitality, or other data-sensitive industries is a plus. Additional Leadership Expectations: Strong problem-solving and analytical skills. Ability to provide technical leadership and mentor team members. Excellent communication skills and the ability to collaborate with and influence cross-functional teams. Ability to balance multiple priorities and deliver high-quality outcomes on time. COMPETENCIES: Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments. Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget. PHYSICAL DEMANDS AND WORK ENVIRONMENT: Occasionally required to stand Occasionally required to walk Continually required to sit Continually required to utilize hand and finger dexterity Frequently required to talk or hear While performing the duties of this job, the noise level in the work environment is usually moderate The employee must occasionally lift and/or move up to 10 pounds Specific vision abilities required by this job include: Close Vision
09/25/2026
Full time
Job DescriptionJob Description At AmaWaterways, we believe meaningful careers begin with purpose, passion and a shared commitment to delivering unforgettable experiences. For those who value curiosity, connection and personal enrichment, AmaWaterways offers the opportunity to help craft meaningful river journeys that invite travelers to follow their own current. Built on a foundation of heartfelt hospitality, we treat our guests-and each other-with genuine care, warmth and respect. AmaWaterways fosters a collaborative environment both onboard our ships and across our global network of offices, where team members grow together, support one another and take pride in upholding the high standards and thoughtful service our company is known for. We invite talented, motivated professionals to explore our career opportunities and begin their journey with AmaWaterways today. This position is primarily responsible for leading and growing the quality assurance function across the company's web platform, APIs, integrations, and supporting services. The QA Manager owns the overall QA strategy, standards, and processes; manages and develops the QA team; and partners with engineering, product, and DevOps to ensure releases are predictable, reliable, and delivered with confidence. DUTIES AND RESPONSIBILITIES: Defines, owns, and continuously improves the end-to-end QA strategy across web, mobile-web, backend services, and integrations. Leads, mentors, and grows a team of QA specialists, automation engineers, and SDETs, fostering a culture of quality and accountability. Establishes and maintains QA standards, test plans, regression suites, smoke-test procedures, and release sign-off processes. Champions shift-left testing and embeds quality practices across the engineering organization. Identifies critical user journeys and high-risk areas, ensuring appropriate test coverage at each layer of the test pyramid. Sets the direction for automation frameworks across UI, API, and integration testing, and ensures suites are robust, maintainable, and trusted. Oversees integration of automated tests into CI/CD pipelines, and defines quality gates, deployment criteria, and rollback triggers in collaboration with DevOps. Owns release readiness and sign-off, ensuring consistent, repeatable, and low-risk deployments across Dev, QA, UAT, and Production. Defines, tracks, and reports on key quality metrics such as defect leakage, escape rate, test coverage, flakiness, MTTD, and MTTR. Provides clear, regular quality reporting and risk assessments to engineering leadership and business stakeholders. Manages relationships with external QA vendors and tooling providers, and contributes to build-versus-buy decisions. Analyzes production incidents to identify gaps in coverage and process, and drives corrective and preventive actions. Establishes and maintains quality governance, including audit readiness, compliance, and data-handling considerations relevant to the business. Evaluates and introduces new tools, technologies, and methodologies to advance the QA function. Provides project effort estimations and resource planning for QA activities across competing priorities. Communicates effectively with technical and non-technical groups, both internally and externally. Maintains current knowledge of relevant technology and quality engineering practices, as assigned. Participates in special projects, as required. Performs other related duties as assigned by management. SUPERVISORY RESPONSIBILITIES: This job carries out supervisory responsibilities in accordance with the organization's policies and applicable laws: Provides day-to-day leadership, mentorship, and technical direction to QA team members. Leads interviewing, evaluation, and hiring of QA specialists, automation engineers, and SDETs. Owns onboarding and training to ensure adherence to quality standards and best practices. Assigns work, monitors progress, and ensures timely delivery of testing and release activities. Conducts performance discussions, sets goals, and supports the professional development of team members. Manages capacity and resource allocation across projects, releases, and competing priorities. Addresses workplace or project-related concerns and escalates issues when appropriate. QUALIFICATIONS: Bachelor's Degree (BA/BS) from a four-year college or university, or seven or more years of related experience and/or training, or an equivalent combination of education and experience. Seven or more years of professional QA experience, with at least three years in a lead or management capacity. Proven track record of building, leading, and scaling QA teams and functions. Computer skills required: Microsoft Office Suite; Project Management Software; Test Management and Defect Tracking Software (e.g., Jira); Database Software; Development Software; Internet Software; Spreadsheet Software; Word Processing Software; Electronic Mail Software; Presentation Software. Other skills required: Strong technical foundation in test automation, with hands-on experience in UI automation (Playwright, Cypress, or Selenium) and API testing tools (Postman/Newman, REST Assured, or Pact). Experience defining QA strategy and embedding quality practices across engineering organizations. Solid understanding of CI/CD pipelines and integrating automated testing into delivery workflows (Azure DevOps, GitHub Actions, Jenkins, or similar). Strong grasp of testing methodologies: TDD, BDD, the test pyramid, risk-based testing, and exploratory testing. Solid understanding of REST APIs, HTTP, authentication mechanisms (OAuth, JWT), and API contract testing. Experience with version control (Git) and code review practices. Strong experience with relational databases and writing SQL queries for data validation and analysis. Demonstrated people-management skills: hiring, mentoring, performance management, and resource planning. Cloud, DevOps, and CI/CD: Familiarity with cloud platforms (preferably Microsoft Azure), including app hosting, storage, networking, and security concepts. Experience embedding automated build, test, and deployment quality gates across multiple environments (Dev, QA, UAT, Prod). Experience with application monitoring, logging, and alerting in cloud environments (e.g., Datadog, New Relic, Grafana, Sentry). Performance and load testing experience with k6, JMeter, or Gatling is a plus. Security Methodology: Knowledge of secure coding and application security principles (e.g., OWASP Top 10) and security testing fundamentals. Experience working in Agile/Scrum environments; Scrum Master experience is a plus. ISTQB Advanced Level certification, or other relevant quality/leadership certification, is a plus. Experience managing QA in travel, hospitality, or other data-sensitive industries is a plus. Additional Leadership Expectations: Strong problem-solving and analytical skills. Ability to provide technical leadership and mentor team members. Excellent communication skills and the ability to collaborate with and influence cross-functional teams. Ability to balance multiple priorities and deliver high-quality outcomes on time. COMPETENCIES: Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments. Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget. PHYSICAL DEMANDS AND WORK ENVIRONMENT: Occasionally required to stand Occasionally required to walk Continually required to sit Continually required to utilize hand and finger dexterity Frequently required to talk or hear While performing the duties of this job, the noise level in the work environment is usually moderate The employee must occasionally lift and/or move up to 10 pounds Specific vision abilities required by this job include: Close Vision
Job DescriptionJob Description OVERVIEW We are seeking Quality Assurance Specialists with varying levels of experience to join Hendall Inc. These roles will focus conducting software development quality assurance activities including integration testing, system testing, regression testing, performance testing and acceptance testing. These individuals will work closely with other Quality Assurance Specialists, Business Analyst(s), Software Developer(s) and Project Leads to define, document and test all business and technical requirements necessary to satisfy product owner's needs. They will also work with the software development team and project management to help manage scope of sprints and releases. The Quality Assurance Specialist will support project risk management activities to ensure all deliverables are delivered with consistently high quality with minimum defects. DUTIES Support all quality assurance activities Review and analyze system specifications Develop effective strategies and test plans Execute test cases (manual or automated) and analyze results Evaluate product code according to specifications Create logs to document testing phases and defects Report bugs and errors to development teams Help troubleshoot issues Conduct post-release/ post-implementation testing Work with cross-functional teams to ensure quality throughout the software development lifecycle Ensure compliance with all federal accessibility standards and guidelines Identify and manage project risks Provide documentation in the form of Test Management Plans, Test Cases and Test Reports throughout the complete software development lifecycle Perform other duties as assigned by supervisor or manager MINIMUM QUALIFICATIONS At least 3-8 years of experience in quality assurance and application testing Working knowledge of at least one Section 508 compliance tools (JAWS preferably) Experience using JIRA Defect Management Tool Demonstrated experience in creating and executing test scripts, and communicating results to management Strong verbal and written communication skills Highly organized and detail oriented Flexible, versatile, and works well under pressure Bachelor's Degree in Computer Science, Engineering, related IT field of equivalent experience PREFERRED QUALIFICATIONS Experience performing backend database testing Experience using automated test tools (Selenium, JMeter, Python Testing Frameworks) is a plus Experience with Capability Maturity Model Integration (CMMI) Strong sense of urgency and ability to prioritize Experience in software development Salary Range: $85,000/year to $125,000/year For a complete listing of benefits, please visit our careers page at Hendall Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
09/25/2026
Full time
Job DescriptionJob Description OVERVIEW We are seeking Quality Assurance Specialists with varying levels of experience to join Hendall Inc. These roles will focus conducting software development quality assurance activities including integration testing, system testing, regression testing, performance testing and acceptance testing. These individuals will work closely with other Quality Assurance Specialists, Business Analyst(s), Software Developer(s) and Project Leads to define, document and test all business and technical requirements necessary to satisfy product owner's needs. They will also work with the software development team and project management to help manage scope of sprints and releases. The Quality Assurance Specialist will support project risk management activities to ensure all deliverables are delivered with consistently high quality with minimum defects. DUTIES Support all quality assurance activities Review and analyze system specifications Develop effective strategies and test plans Execute test cases (manual or automated) and analyze results Evaluate product code according to specifications Create logs to document testing phases and defects Report bugs and errors to development teams Help troubleshoot issues Conduct post-release/ post-implementation testing Work with cross-functional teams to ensure quality throughout the software development lifecycle Ensure compliance with all federal accessibility standards and guidelines Identify and manage project risks Provide documentation in the form of Test Management Plans, Test Cases and Test Reports throughout the complete software development lifecycle Perform other duties as assigned by supervisor or manager MINIMUM QUALIFICATIONS At least 3-8 years of experience in quality assurance and application testing Working knowledge of at least one Section 508 compliance tools (JAWS preferably) Experience using JIRA Defect Management Tool Demonstrated experience in creating and executing test scripts, and communicating results to management Strong verbal and written communication skills Highly organized and detail oriented Flexible, versatile, and works well under pressure Bachelor's Degree in Computer Science, Engineering, related IT field of equivalent experience PREFERRED QUALIFICATIONS Experience performing backend database testing Experience using automated test tools (Selenium, JMeter, Python Testing Frameworks) is a plus Experience with Capability Maturity Model Integration (CMMI) Strong sense of urgency and ability to prioritize Experience in software development Salary Range: $85,000/year to $125,000/year For a complete listing of benefits, please visit our careers page at Hendall Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Job DescriptionJob DescriptionCompany Description With over $2B in revenue, 80+ manufacturing facilities across 6 continents and over 9,000 employees worldwide, Signode is a leading manufacturer of a broad spectrum of transit packaging consumables, tools, software, and equipment that optimize end-of-line packaging operations and protect products in transit. Signode brings this extensive product portfolio together under hundreds of trusted brands to offer complete transit packaging solutions to its customers. We produce strap, stretch and protective packaging. We also manufacture packaging tools and equipment used to apply the bulk packaging materials. These commercial packaging products are used to pack, bundle, unitize, protect, and secure goods during warehousing and transit. Our company is a pioneer in the industrial packaging sector with a long history of customer-focused innovations in materials, processes and automation technology that have revolutionized the sector. Headquartered in Tampa, Florida, we are proud to be the Transit Packaging Division of Crown Holdings, Inc. We are excited to go to market as Signode and to share the portfolio of products, services and capabilities that make us the world's premier end-of-line packaging company. Job Description Benefits: Signode offers a comprehensive benefits package to full-time employees, which includes health, dental, vision, 401k, paid time off, life insurance, wellness perks, and more. Benefits begin the month following the hire date. Salary: The annual salary for this position ranges from $127,000 - $152,000 + 10% bonus target and varies based on specific responsibilities and geographic location. Starting annual salary within this range will be determined based on the candidate's experience, qualifications, and/or skillset. Summary We are seeking a highly experienced and versatile Manager, Application Delivery & QA to lead IT application delivery and quality assurance across our enterprise and local application portfolio. This role is accountable for application delivery, quality governance, testing strategy, test automation, and execution across enterprise application initiatives. The position combines App Delivery management with hands-on QA leadership to ensure projects are delivered with strong testing discipline, business readiness, SOX compliance, and measurable quality outcomes. This role supports a diverse application portfolio that includes major enterprise platforms such as Microsoft Dynamics 365 Finance & Operations, Dynamics 365 Customer Engagement (CE), AX 2012, third-party applications, custom-developed solutions, and system integrations. The successful candidate will serve as a key liaison between business stakeholders and different IT teams to drive high-quality project delivery. This position is well suited for an experienced IT leader who can effectively balance multiple priorities while operating across quality assurance, application delivery, project governance, stakeholder management, and organizational change management. Essential Functions Technical Project Management & Agile Delivery Lead IT application projects from initiation through deployment Manage project scope, timelines, budgets, risks, dependencies, and resource planning Facilitate Agile ceremonies including Sprint Planning, Daily Standups, Backlog Grooming, Sprint Reviews, Retrospectives Partner with business stakeholders to define priorities and roadmap objectives Translate business requirements into actionable user stories and technical work items Coordinate development, QA, infrastructure, and business teams to ensure successful delivery Track project progress and communicate status, risks, and mitigation plans to leadership Manage relationships with implementation partners and third-party vendors Quality Assurance & Testing Leadership Establish and maintain Enterprise Apps testing standards, methodologies, and governance processes adhering to SOX compliance for the Global projects with a major focus on Global ERP rollout Use an AI-first approach and look for ways to utilize AI to streamline delivery of QA, App Delivery, and Projects Work with matrix internal IT teams and end users, Lead SIT, UAT, regression, integration, and release testing activities Develop and oversee comprehensive test strategies and test plans Create and review test scenarios, test scripts, and business process validation documents Manage defect lifecycle processes and defect triage activities Ensure appropriate testing coverage for Finance, Manufacturing, Supply Chain, Procurement, Inventory, and Order Management processes Drive continuous improvement of testing practices and quality metrics Conduct go-live assessment and testing sign-offs working hand in hand with business teams as well as the compliance team. Support apps other than ERP for testing and sign-off process Manage test planning and execution using Azure DevOps Create and maintain: Test Plans, Test Suites, User Stories, Defect Tracking, Requirements Traceability Drive adoption of ERP test automation solutions, preferably Test Mart Develop automated regression testing strategies and improve test efficiency Build KPI dashboards to monitor testing quality, defect trends, and release readiness Document and communicate Test cases, SOPs, and changes to business stakeholders. Team Leadership Provide leadership, mentoring, and coaching to QA and support team members. Allocate workload and ensure resource optimization across projects and support functions. Establish performance objectives and development plans for team members. Promote quality, accountability, and continuous improvement within the team. Qualifications Education: A bachelor's degree in computer science, data science, Information Technology, or an engineering field, or at least nine (9) years of professional experience in a similar technology role Experience: 7 - 9 years of experience working as an IT Delivery Manager or QA Manager. In addition: Minimum 7+ years of experience in ERP QA execution and delivery and IT apps project delivery 6+ years of experience conducting UAT for large-scale global ERP projects, minimum 2 5+ years of experience leading technical projects as a scrum master or technical PM Experience leading small technical or QA teams Strong functional/technical experience with: Microsoft Dynamics 365 Finance & Operations, CE Microsoft Dynamics AX 2012 Experience supporting enterprise ERP environments and Other Apps, including CRM, within manufacturing, distribution, or supply chain-focused organizations 6+ years of experience managing Azure DevOps and testing documentation and plans 5+ years of experience with Testing automation software, with 3+ years working with TestMart to develop test suite automation 5+ years of config and admin experience of ITSM tools like Freshworks or ServiceNow 3+ years of experience working with Azure Industry experience working in a technical environment, preferably in manufacturing An ability to manage multiple complex projects concurrently and autonomously A high aptitude for QA leadership for global ERP rollouts Ability to influence decision-making processes and foster an environment of healthy team debate Strong risk awareness and the ability to identify imminent risks Strong communication and presentation skills Experience leading global teams in a matrix environment Functional Success Drivers: These competencies are what we require for an individual to be successful in this role: Leadership Communication Strategic Skills Excellence Results-Oriented Leading Edge Additional Information All your information will be kept confidential according to EEO guidelines. The Company does not sponsor for employment-based visas for this position now or in the future. Reasonable Accommodation Statement To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities. Signode is committed to providing equal opportunities to all qualified applicants, including providing reasonable accommodations during our recruiting process. If you need any assistance or accommodation in applying for this position, please contact us at . The Company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the Company reserves the right to change this job description and/or assign tasks for the employee to perform, as the Company may deem appropriate. Signode participates in E-Verify and will provide the Department of Homeland Security your Form I-9 information to confirm your authorization to work in the United States. . click apply for full job details
09/25/2026
Full time
Job DescriptionJob DescriptionCompany Description With over $2B in revenue, 80+ manufacturing facilities across 6 continents and over 9,000 employees worldwide, Signode is a leading manufacturer of a broad spectrum of transit packaging consumables, tools, software, and equipment that optimize end-of-line packaging operations and protect products in transit. Signode brings this extensive product portfolio together under hundreds of trusted brands to offer complete transit packaging solutions to its customers. We produce strap, stretch and protective packaging. We also manufacture packaging tools and equipment used to apply the bulk packaging materials. These commercial packaging products are used to pack, bundle, unitize, protect, and secure goods during warehousing and transit. Our company is a pioneer in the industrial packaging sector with a long history of customer-focused innovations in materials, processes and automation technology that have revolutionized the sector. Headquartered in Tampa, Florida, we are proud to be the Transit Packaging Division of Crown Holdings, Inc. We are excited to go to market as Signode and to share the portfolio of products, services and capabilities that make us the world's premier end-of-line packaging company. Job Description Benefits: Signode offers a comprehensive benefits package to full-time employees, which includes health, dental, vision, 401k, paid time off, life insurance, wellness perks, and more. Benefits begin the month following the hire date. Salary: The annual salary for this position ranges from $127,000 - $152,000 + 10% bonus target and varies based on specific responsibilities and geographic location. Starting annual salary within this range will be determined based on the candidate's experience, qualifications, and/or skillset. Summary We are seeking a highly experienced and versatile Manager, Application Delivery & QA to lead IT application delivery and quality assurance across our enterprise and local application portfolio. This role is accountable for application delivery, quality governance, testing strategy, test automation, and execution across enterprise application initiatives. The position combines App Delivery management with hands-on QA leadership to ensure projects are delivered with strong testing discipline, business readiness, SOX compliance, and measurable quality outcomes. This role supports a diverse application portfolio that includes major enterprise platforms such as Microsoft Dynamics 365 Finance & Operations, Dynamics 365 Customer Engagement (CE), AX 2012, third-party applications, custom-developed solutions, and system integrations. The successful candidate will serve as a key liaison between business stakeholders and different IT teams to drive high-quality project delivery. This position is well suited for an experienced IT leader who can effectively balance multiple priorities while operating across quality assurance, application delivery, project governance, stakeholder management, and organizational change management. Essential Functions Technical Project Management & Agile Delivery Lead IT application projects from initiation through deployment Manage project scope, timelines, budgets, risks, dependencies, and resource planning Facilitate Agile ceremonies including Sprint Planning, Daily Standups, Backlog Grooming, Sprint Reviews, Retrospectives Partner with business stakeholders to define priorities and roadmap objectives Translate business requirements into actionable user stories and technical work items Coordinate development, QA, infrastructure, and business teams to ensure successful delivery Track project progress and communicate status, risks, and mitigation plans to leadership Manage relationships with implementation partners and third-party vendors Quality Assurance & Testing Leadership Establish and maintain Enterprise Apps testing standards, methodologies, and governance processes adhering to SOX compliance for the Global projects with a major focus on Global ERP rollout Use an AI-first approach and look for ways to utilize AI to streamline delivery of QA, App Delivery, and Projects Work with matrix internal IT teams and end users, Lead SIT, UAT, regression, integration, and release testing activities Develop and oversee comprehensive test strategies and test plans Create and review test scenarios, test scripts, and business process validation documents Manage defect lifecycle processes and defect triage activities Ensure appropriate testing coverage for Finance, Manufacturing, Supply Chain, Procurement, Inventory, and Order Management processes Drive continuous improvement of testing practices and quality metrics Conduct go-live assessment and testing sign-offs working hand in hand with business teams as well as the compliance team. Support apps other than ERP for testing and sign-off process Manage test planning and execution using Azure DevOps Create and maintain: Test Plans, Test Suites, User Stories, Defect Tracking, Requirements Traceability Drive adoption of ERP test automation solutions, preferably Test Mart Develop automated regression testing strategies and improve test efficiency Build KPI dashboards to monitor testing quality, defect trends, and release readiness Document and communicate Test cases, SOPs, and changes to business stakeholders. Team Leadership Provide leadership, mentoring, and coaching to QA and support team members. Allocate workload and ensure resource optimization across projects and support functions. Establish performance objectives and development plans for team members. Promote quality, accountability, and continuous improvement within the team. Qualifications Education: A bachelor's degree in computer science, data science, Information Technology, or an engineering field, or at least nine (9) years of professional experience in a similar technology role Experience: 7 - 9 years of experience working as an IT Delivery Manager or QA Manager. In addition: Minimum 7+ years of experience in ERP QA execution and delivery and IT apps project delivery 6+ years of experience conducting UAT for large-scale global ERP projects, minimum 2 5+ years of experience leading technical projects as a scrum master or technical PM Experience leading small technical or QA teams Strong functional/technical experience with: Microsoft Dynamics 365 Finance & Operations, CE Microsoft Dynamics AX 2012 Experience supporting enterprise ERP environments and Other Apps, including CRM, within manufacturing, distribution, or supply chain-focused organizations 6+ years of experience managing Azure DevOps and testing documentation and plans 5+ years of experience with Testing automation software, with 3+ years working with TestMart to develop test suite automation 5+ years of config and admin experience of ITSM tools like Freshworks or ServiceNow 3+ years of experience working with Azure Industry experience working in a technical environment, preferably in manufacturing An ability to manage multiple complex projects concurrently and autonomously A high aptitude for QA leadership for global ERP rollouts Ability to influence decision-making processes and foster an environment of healthy team debate Strong risk awareness and the ability to identify imminent risks Strong communication and presentation skills Experience leading global teams in a matrix environment Functional Success Drivers: These competencies are what we require for an individual to be successful in this role: Leadership Communication Strategic Skills Excellence Results-Oriented Leading Edge Additional Information All your information will be kept confidential according to EEO guidelines. The Company does not sponsor for employment-based visas for this position now or in the future. Reasonable Accommodation Statement To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities. Signode is committed to providing equal opportunities to all qualified applicants, including providing reasonable accommodations during our recruiting process. If you need any assistance or accommodation in applying for this position, please contact us at . The Company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the Company reserves the right to change this job description and/or assign tasks for the employee to perform, as the Company may deem appropriate. Signode participates in E-Verify and will provide the Department of Homeland Security your Form I-9 information to confirm your authorization to work in the United States. . click apply for full job details
Job DescriptionJob Description Bal Seal Engineering is seeking a QC Supervisor to support the Quality Assurance department in overseeing all Quality inspection activity from Receiving Inspection to Shipping Audit as well as supporting interdepartmental projects and studies with Quality Assurance knowledge and resources. The Quality Assurance Supervisor manages the hourly Quality personnel and is their main point of contact for questions and support. About Bal Seal: Bal Seal Engineering delivers advanced sealing, connecting, and contact solutions that serve medical, aerospace, energy, and industrial markets. Our proprietary spring-energized seals and electrical contacts help customers achieve precision, efficiency, and reliability. Employees thrive in a culture that values craftsmanship, technical mastery, and close partnership with customers solving complex challenges. Reports to: QA Manager Department: QA Essential Duties and Responsibilities: Develop, train, direct, coach, counsel, communicate to, monitor, appraise and manage personnel Ensure compliance to all company-wide and Quality Assurance-specific procedures Manage the MRB and Calibration processes Coordinate with Production Control to assist in meeting Production goals and to ensure inspection is completed in a timely manner Manage department to ensure inspection resources are properly allocated Establish performance metrics for inspection personnel and evaluate them accordingly Perform other related duties as assigned Education: Bachelor's Degree in Business, Management, or a STEM field preferred LSS Green Belt preferred Experience: Minimum 5 years in a quality role Leadership experience preferred Knowledge, Skills and Abilities: Strong leadership skills that inspire team with confidence and respect while motivating the members in a creative and effective manner Excellent interpersonal skills Advanced computer skills (i.e. creating and revising procedures, people management software, creating forms, data manipulation) Intermediate software knowledge of Microsoft Office Suite (e.g. email, calendar, creating tables, graphs, performing calculations, using plug-ins) Experience with product lifecycle management software (e.g. Agile) Experience with enterprise resource planning software (e.g. E1) Ability to learn and navigate custom/specialized software Ability to comprehend written instructions with industry-specific terms and technical concepts Familiarity with inspection plans Familiarity with statistical process control (SPC) Ability to use manual gauges (e.g. micrometers, calipers, scales) Intermediate knowledge of visual inspection systems (i.e. Smartscope) Experience with mechanical test equipment (e.g. Chatillon force tester, United tensile tester, surface profilometer) Understanding of a QMS based on ISO 9001/AS9100 requirements Ability to problem solve Basic understanding of statistical methods (AQL, mean, variation, control charts, histograms) Ability to speak, read, and write in English with technical proficiency (required) Ability to speak Spanish (preferred) Physical Requirements: This position is mainly sedentary; Therefore, required to sit Prolonged periods of sitting at a desk and working on a computer While performing the duties of this job, the employee is occasionally required to walk throughout the facility Frequent lifting and/or moving up to 10 pounds and occasionally lifting and/or move up to 25 pounds Occasionally will need to bend, stoop and squat Work Environment: The work environment conditions are typical of a manufacturing environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the basic functions. The noise level in the work environment ranges from quiet to moderate, however, hearing protection may be required if employee enters high noise areas as a part of their normal job duties. Benefits: At Bal Seal Engineering (BSE) we recognize how important your career and benefits are to you and your family. We offer a full suite of benefits, including medical, dental, vision, short and long-term disability coverage, accident insurance, critical illness insurance, basic and supplemental life insurance, employee assistance plan, retirement savings and matching, and other developmental opportunities. We are committed to supporting the way you live and work. BSE is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status. Applicants requiring reasonable accommodation to complete the application process may contact Human Resources. This position requires access to information subject to the International Traffic in Arms Regulations (ITAR). Employment is contingent upon the applicant being a "U.S. person" as defined by ITAR (22 CFR 120.15), which includes U.S. citizens, lawful permanent residents, refugees, or asylees, as required by U.S. export control laws. 8am - 5pm
09/25/2026
Full time
Job DescriptionJob Description Bal Seal Engineering is seeking a QC Supervisor to support the Quality Assurance department in overseeing all Quality inspection activity from Receiving Inspection to Shipping Audit as well as supporting interdepartmental projects and studies with Quality Assurance knowledge and resources. The Quality Assurance Supervisor manages the hourly Quality personnel and is their main point of contact for questions and support. About Bal Seal: Bal Seal Engineering delivers advanced sealing, connecting, and contact solutions that serve medical, aerospace, energy, and industrial markets. Our proprietary spring-energized seals and electrical contacts help customers achieve precision, efficiency, and reliability. Employees thrive in a culture that values craftsmanship, technical mastery, and close partnership with customers solving complex challenges. Reports to: QA Manager Department: QA Essential Duties and Responsibilities: Develop, train, direct, coach, counsel, communicate to, monitor, appraise and manage personnel Ensure compliance to all company-wide and Quality Assurance-specific procedures Manage the MRB and Calibration processes Coordinate with Production Control to assist in meeting Production goals and to ensure inspection is completed in a timely manner Manage department to ensure inspection resources are properly allocated Establish performance metrics for inspection personnel and evaluate them accordingly Perform other related duties as assigned Education: Bachelor's Degree in Business, Management, or a STEM field preferred LSS Green Belt preferred Experience: Minimum 5 years in a quality role Leadership experience preferred Knowledge, Skills and Abilities: Strong leadership skills that inspire team with confidence and respect while motivating the members in a creative and effective manner Excellent interpersonal skills Advanced computer skills (i.e. creating and revising procedures, people management software, creating forms, data manipulation) Intermediate software knowledge of Microsoft Office Suite (e.g. email, calendar, creating tables, graphs, performing calculations, using plug-ins) Experience with product lifecycle management software (e.g. Agile) Experience with enterprise resource planning software (e.g. E1) Ability to learn and navigate custom/specialized software Ability to comprehend written instructions with industry-specific terms and technical concepts Familiarity with inspection plans Familiarity with statistical process control (SPC) Ability to use manual gauges (e.g. micrometers, calipers, scales) Intermediate knowledge of visual inspection systems (i.e. Smartscope) Experience with mechanical test equipment (e.g. Chatillon force tester, United tensile tester, surface profilometer) Understanding of a QMS based on ISO 9001/AS9100 requirements Ability to problem solve Basic understanding of statistical methods (AQL, mean, variation, control charts, histograms) Ability to speak, read, and write in English with technical proficiency (required) Ability to speak Spanish (preferred) Physical Requirements: This position is mainly sedentary; Therefore, required to sit Prolonged periods of sitting at a desk and working on a computer While performing the duties of this job, the employee is occasionally required to walk throughout the facility Frequent lifting and/or moving up to 10 pounds and occasionally lifting and/or move up to 25 pounds Occasionally will need to bend, stoop and squat Work Environment: The work environment conditions are typical of a manufacturing environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the basic functions. The noise level in the work environment ranges from quiet to moderate, however, hearing protection may be required if employee enters high noise areas as a part of their normal job duties. Benefits: At Bal Seal Engineering (BSE) we recognize how important your career and benefits are to you and your family. We offer a full suite of benefits, including medical, dental, vision, short and long-term disability coverage, accident insurance, critical illness insurance, basic and supplemental life insurance, employee assistance plan, retirement savings and matching, and other developmental opportunities. We are committed to supporting the way you live and work. BSE is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status. Applicants requiring reasonable accommodation to complete the application process may contact Human Resources. This position requires access to information subject to the International Traffic in Arms Regulations (ITAR). Employment is contingent upon the applicant being a "U.S. person" as defined by ITAR (22 CFR 120.15), which includes U.S. citizens, lawful permanent residents, refugees, or asylees, as required by U.S. export control laws. 8am - 5pm
Job DescriptionJob DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS Bachelor's Degree in a Scientific or Engineering discipline 8 + years of computerized system experience with IT compliance/validation/qualification activities. 8 + years of experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. 10% travel required. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
09/25/2026
Full time
Job DescriptionJob DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS Bachelor's Degree in a Scientific or Engineering discipline 8 + years of computerized system experience with IT compliance/validation/qualification activities. 8 + years of experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. 10% travel required. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Job DescriptionJob DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS Bachelor's Degree in a Scientific or Engineering discipline 8 + years of computerized system experience with IT compliance/validation/qualification activities. 8 + years of experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. 10% travel required. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
09/25/2026
Full time
Job DescriptionJob DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS Bachelor's Degree in a Scientific or Engineering discipline 8 + years of computerized system experience with IT compliance/validation/qualification activities. 8 + years of experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. 10% travel required. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Job DescriptionJob Description Career Team is a leading workforce development organization on a mission to transform lives. We blend cutting-edge technology with compassionate, high-touch services to drive real, measurable outcomes in the lives of job seekers across the country. At Career Team, we're solving today's unemployment challenges with smart software, world-class trainers, dedicated case managers, dynamic job developers, and innovative partners. If you're passionate about making a difference and believe in the power of technology to transform lives, you'll feel right at home here. TITLE: Quality Assurance Specialist REPORTS TO: Quality Assurance Manager LOCATION: Deep East Texas Workforce Development Area EMPLOYMENT TYPE: Full-Time, Non-Exempt Employee Career Team is looking to hire a Quality Assurance Specialist responsible for conducting case file reviews, monitoring data integrity, and ensuring program compliance with contract requirements. This role identifies deficiencies, supports corrective action, and contributes to a culture of continuous improvement across the Deep East Texas project. Work is performed under the supervision of the Quality Assurance Manager. Your Impact on Career Team's Success: Conduct regular reviews of participant case files to evaluate accuracy, completeness, and compliance with federal WIOA/TANF, state, local, and corporate policies Monitor data entered into Work In Texas and other participant information systems for accuracy and timeliness Identify deficiencies and trends, document findings, and recommend corrective action Provide internal monitoring, second reviews, and oversight of program activities and requirements Support staff in resolving file and data issues to ensure no disallowed costs on eligibility Work with staff to ensure correct documents and case notes are entered into the system for all services provided to customers Prepare and present quality assurance reports and dashboards to project leadership Assist with preparation for and response to program monitoring and audits Support the development and continuous improvement of policies, procedures, and quality management practices Partner with the Quality Assurance Manager to address recurring issues through targeted staff training Support the invoicing and expenditure compliance relationship between the funder and the corporate fiscal team, including timely invoice corrections Process participant exits from the database to hard file in coordination with the leadership team Serve as a subject matter expert in program compliance and policy Maintain up-to-date knowledge of standard operating procedures and contract updates Maintain a high level of accuracy and confidentiality in handling participant information Approach each day and task with a "ZAG" mindset Other duties and projects as needed This position is expected to be 100% onsite. The selected candidate will be required to work onsite at the listed location. To Qualify for This Role, You Must Have: Bachelor's degree, or an equivalent combination of education and experience 2+ years of experience in quality assurance, monitoring, compliance, or case management Knowledge of WIOA, TANF, and/or SNAP eligibility and documentation requirements Sharp attention to detail with strong organizational, analytical, research, and critical thinking skills Computer literate with strong MS Excel skills and the ability to learn specialized databases and software systems Ability to work across all levels of management and staff in a dynamic team environment Excellent interpersonal and communication skills (oral and written) Exceptional time management skills to meet deadlines and complete a high volume of work with speed and accuracy A demonstrated ability to thrive in a fast-paced environment while maintaining a high level of confidentiality A Valid Driver's License Additional Skills/Knowledge Career Team Would Love for This Role: Experience conducting case file reviews or audits in a workforce development setting Master's or MBA degree Strong computer skills in MS Excel and Google Sheets Bilingual or multilingual Salary: $38,000 - $40,000 /yr Salary is commensurate with education and experience. Career TEAM offers a competitive benefits package including healthcare, dental, and personal/vacation time Travel: As needed About Career Team: Founded in 1996, Career Team, LLC is a private workforce development organization. Career Team's outstanding record of accelerating the human condition has resulted in numerous honors: Named by Inc. Magazine as one of America's 500 fastest growing privately held companies Recipient of the US Chamber of Commerce Blue Chip Enterprise Award for innovation Featured by 60 Minutes, CNN, Money Magazine, Inc. Magazine and the British Broadcasting Network as an innovative, government funded solutions program Invited to the White House after being cited by the National Welfare-to-Work Partnership and National Alliance of Business as a top 10 US training provider As a socially conscious organization, Career Team has found a healthy balance between for-profit innovation and community enrichment. Looking ahead, the organization will continue to close the nation's opportunity divide with additional government-funded workforce sites; while also building staff capacity of workforce funding sources and industry providers. See for more information. Career Team is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. Background Check Requirements. Employment is contingent upon successful completion of a background check (including criminal, prior employment and education verification). Failure to satisfactorily complete the background check may affect the application status of applicants or continued employment of current employees who apply for the position. California Consumer Privacy Act ("CCPA"). Career Team is committed to complying with the CCPA and all data privacy and laws in the jurisdictions in which it recruits and hires employees. Career Team collects and uses Personal Information for human resources, employment, benefits administration, health and safety, and business-related purposes and to be in legal compliance. Below are the categories of Personal Information we collect and the purposes for which we intend to use this information: Identifying information, such as your full name, gender, date of birth, and signature; Demographic data, such as race, ethnic origin, marital status, disability, and veteran or military status; Contact information, such as your home address, telephone numbers, email addresses, and emergency contact information; Dependent's or other individual's information, such as their full name, address, date of birth, and Social Security numbers (SSN); National identifiers, such as SSN, passport and visa information, and immigration status and documentation; Educational and professional background, such as your work history, academic and professional qualifications, educational records, references, and interview notes; Employment details, such as your job title, position, hire dates, compensation, performance and disciplinary records, and vacation and sick leave records; Financial information, such as banking details, tax information, payroll information, and withholdings; Health and Safety information, such as health conditions (if relevant to your employment), job restrictions, workplace illness and injury information, and health insurance policy information; Information Systems (IS) information, such as your search history, browsing history, login information, and IP addresses on the Company's information systems and networks; Biometric information, such as facial recognition, fingerprints, iris or retina scans, keystroke, or other physical patterns; and Geolocation data, such as time and physical location related to use of an internet website, application, device, or physical access to a Company office location. The Company collects Personal Information to use or disclose as appropriate to: (1) Comply with all applicable laws and regulations; (2) Recruit and evaluate job applicants and candidates for employment; (3) Conduct background checks; (4) Manage your employment relationship with us, including for: (a) onboarding processes; (b) timekeeping, payroll, and expense report administration; (c) employee benefits administration; (d) employee training and development requirements; (d) the creation, maintenance, and security of your online employee accounts; (e) reaching your emergency contacts when needed, such as when you are not reachable or are injured or ill; (f) workers' compensation claims management; (g) employee job performance, including goals and performance reviews, promotions, discipline, and termination; and (h) other human resources purposes; (5) Manage and monitor employee access to company facilities, equipment . click apply for full job details
09/25/2026
Full time
Job DescriptionJob Description Career Team is a leading workforce development organization on a mission to transform lives. We blend cutting-edge technology with compassionate, high-touch services to drive real, measurable outcomes in the lives of job seekers across the country. At Career Team, we're solving today's unemployment challenges with smart software, world-class trainers, dedicated case managers, dynamic job developers, and innovative partners. If you're passionate about making a difference and believe in the power of technology to transform lives, you'll feel right at home here. TITLE: Quality Assurance Specialist REPORTS TO: Quality Assurance Manager LOCATION: Deep East Texas Workforce Development Area EMPLOYMENT TYPE: Full-Time, Non-Exempt Employee Career Team is looking to hire a Quality Assurance Specialist responsible for conducting case file reviews, monitoring data integrity, and ensuring program compliance with contract requirements. This role identifies deficiencies, supports corrective action, and contributes to a culture of continuous improvement across the Deep East Texas project. Work is performed under the supervision of the Quality Assurance Manager. Your Impact on Career Team's Success: Conduct regular reviews of participant case files to evaluate accuracy, completeness, and compliance with federal WIOA/TANF, state, local, and corporate policies Monitor data entered into Work In Texas and other participant information systems for accuracy and timeliness Identify deficiencies and trends, document findings, and recommend corrective action Provide internal monitoring, second reviews, and oversight of program activities and requirements Support staff in resolving file and data issues to ensure no disallowed costs on eligibility Work with staff to ensure correct documents and case notes are entered into the system for all services provided to customers Prepare and present quality assurance reports and dashboards to project leadership Assist with preparation for and response to program monitoring and audits Support the development and continuous improvement of policies, procedures, and quality management practices Partner with the Quality Assurance Manager to address recurring issues through targeted staff training Support the invoicing and expenditure compliance relationship between the funder and the corporate fiscal team, including timely invoice corrections Process participant exits from the database to hard file in coordination with the leadership team Serve as a subject matter expert in program compliance and policy Maintain up-to-date knowledge of standard operating procedures and contract updates Maintain a high level of accuracy and confidentiality in handling participant information Approach each day and task with a "ZAG" mindset Other duties and projects as needed This position is expected to be 100% onsite. The selected candidate will be required to work onsite at the listed location. To Qualify for This Role, You Must Have: Bachelor's degree, or an equivalent combination of education and experience 2+ years of experience in quality assurance, monitoring, compliance, or case management Knowledge of WIOA, TANF, and/or SNAP eligibility and documentation requirements Sharp attention to detail with strong organizational, analytical, research, and critical thinking skills Computer literate with strong MS Excel skills and the ability to learn specialized databases and software systems Ability to work across all levels of management and staff in a dynamic team environment Excellent interpersonal and communication skills (oral and written) Exceptional time management skills to meet deadlines and complete a high volume of work with speed and accuracy A demonstrated ability to thrive in a fast-paced environment while maintaining a high level of confidentiality A Valid Driver's License Additional Skills/Knowledge Career Team Would Love for This Role: Experience conducting case file reviews or audits in a workforce development setting Master's or MBA degree Strong computer skills in MS Excel and Google Sheets Bilingual or multilingual Salary: $38,000 - $40,000 /yr Salary is commensurate with education and experience. Career TEAM offers a competitive benefits package including healthcare, dental, and personal/vacation time Travel: As needed About Career Team: Founded in 1996, Career Team, LLC is a private workforce development organization. Career Team's outstanding record of accelerating the human condition has resulted in numerous honors: Named by Inc. Magazine as one of America's 500 fastest growing privately held companies Recipient of the US Chamber of Commerce Blue Chip Enterprise Award for innovation Featured by 60 Minutes, CNN, Money Magazine, Inc. Magazine and the British Broadcasting Network as an innovative, government funded solutions program Invited to the White House after being cited by the National Welfare-to-Work Partnership and National Alliance of Business as a top 10 US training provider As a socially conscious organization, Career Team has found a healthy balance between for-profit innovation and community enrichment. Looking ahead, the organization will continue to close the nation's opportunity divide with additional government-funded workforce sites; while also building staff capacity of workforce funding sources and industry providers. See for more information. Career Team is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. Background Check Requirements. Employment is contingent upon successful completion of a background check (including criminal, prior employment and education verification). Failure to satisfactorily complete the background check may affect the application status of applicants or continued employment of current employees who apply for the position. California Consumer Privacy Act ("CCPA"). Career Team is committed to complying with the CCPA and all data privacy and laws in the jurisdictions in which it recruits and hires employees. Career Team collects and uses Personal Information for human resources, employment, benefits administration, health and safety, and business-related purposes and to be in legal compliance. Below are the categories of Personal Information we collect and the purposes for which we intend to use this information: Identifying information, such as your full name, gender, date of birth, and signature; Demographic data, such as race, ethnic origin, marital status, disability, and veteran or military status; Contact information, such as your home address, telephone numbers, email addresses, and emergency contact information; Dependent's or other individual's information, such as their full name, address, date of birth, and Social Security numbers (SSN); National identifiers, such as SSN, passport and visa information, and immigration status and documentation; Educational and professional background, such as your work history, academic and professional qualifications, educational records, references, and interview notes; Employment details, such as your job title, position, hire dates, compensation, performance and disciplinary records, and vacation and sick leave records; Financial information, such as banking details, tax information, payroll information, and withholdings; Health and Safety information, such as health conditions (if relevant to your employment), job restrictions, workplace illness and injury information, and health insurance policy information; Information Systems (IS) information, such as your search history, browsing history, login information, and IP addresses on the Company's information systems and networks; Biometric information, such as facial recognition, fingerprints, iris or retina scans, keystroke, or other physical patterns; and Geolocation data, such as time and physical location related to use of an internet website, application, device, or physical access to a Company office location. The Company collects Personal Information to use or disclose as appropriate to: (1) Comply with all applicable laws and regulations; (2) Recruit and evaluate job applicants and candidates for employment; (3) Conduct background checks; (4) Manage your employment relationship with us, including for: (a) onboarding processes; (b) timekeeping, payroll, and expense report administration; (c) employee benefits administration; (d) employee training and development requirements; (d) the creation, maintenance, and security of your online employee accounts; (e) reaching your emergency contacts when needed, such as when you are not reachable or are injured or ill; (f) workers' compensation claims management; (g) employee job performance, including goals and performance reviews, promotions, discipline, and termination; and (h) other human resources purposes; (5) Manage and monitor employee access to company facilities, equipment . click apply for full job details
Job DescriptionJob Description Bal Seal Engineering is seeking a QC Supervisor to support the Quality Assurance department in overseeing all Quality inspection activity from Receiving Inspection to Shipping Audit as well as supporting interdepartmental projects and studies with Quality Assurance knowledge and resources. The Quality Assurance Supervisor manages the hourly Quality personnel and is their main point of contact for questions and support. About Bal Seal: Bal Seal Engineering delivers advanced sealing, connecting, and contact solutions that serve medical, aerospace, energy, and industrial markets. Our proprietary spring-energized seals and electrical contacts help customers achieve precision, efficiency, and reliability. Employees thrive in a culture that values craftsmanship, technical mastery, and close partnership with customers solving complex challenges. Reports to: QA Manager Department: QA Essential Duties and Responsibilities: Develop, train, direct, coach, counsel, communicate to, monitor, appraise and manage personnel Ensure compliance to all company-wide and Quality Assurance-specific procedures Manage the MRB and Calibration processes Coordinate with Production Control to assist in meeting Production goals and to ensure inspection is completed in a timely manner Manage department to ensure inspection resources are properly allocated Establish performance metrics for inspection personnel and evaluate them accordingly Perform other related duties as assigned Education: Bachelor's Degree in Business, Management, or a STEM field preferred LSS Green Belt preferred Experience: Minimum 5 years in a quality role Leadership experience preferred Knowledge, Skills and Abilities: Strong leadership skills that inspire team with confidence and respect while motivating the members in a creative and effective manner Excellent interpersonal skills Advanced computer skills (i.e. creating and revising procedures, people management software, creating forms, data manipulation) Intermediate software knowledge of Microsoft Office Suite (e.g. email, calendar, creating tables, graphs, performing calculations, using plug-ins) Experience with product lifecycle management software (e.g. Agile) Experience with enterprise resource planning software (e.g. E1) Ability to learn and navigate custom/specialized software Ability to comprehend written instructions with industry-specific terms and technical concepts Familiarity with inspection plans Familiarity with statistical process control (SPC) Ability to use manual gauges (e.g. micrometers, calipers, scales) Intermediate knowledge of visual inspection systems (i.e. Smartscope) Experience with mechanical test equipment (e.g. Chatillon force tester, United tensile tester, surface profilometer) Understanding of a QMS based on ISO 9001/AS9100 requirements Ability to problem solve Basic understanding of statistical methods (AQL, mean, variation, control charts, histograms) Ability to speak, read, and write in English with technical proficiency (required) Ability to speak Spanish (preferred) Physical Requirements: This position is mainly sedentary; Therefore, required to sit Prolonged periods of sitting at a desk and working on a computer While performing the duties of this job, the employee is occasionally required to walk throughout the facility Frequent lifting and/or moving up to 10 pounds and occasionally lifting and/or move up to 25 pounds Occasionally will need to bend, stoop and squat Work Environment: The work environment conditions are typical of a manufacturing environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the basic functions. The noise level in the work environment ranges from quiet to moderate, however, hearing protection may be required if employee enters high noise areas as a part of their normal job duties. Benefits: At Bal Seal Engineering (BSE) we recognize how important your career and benefits are to you and your family. We offer a full suite of benefits, including medical, dental, vision, short and long-term disability coverage, accident insurance, critical illness insurance, basic and supplemental life insurance, employee assistance plan, retirement savings and matching, and other developmental opportunities. We are committed to supporting the way you live and work. BSE is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status. Applicants requiring reasonable accommodation to complete the application process may contact Human Resources. This position requires access to information subject to the International Traffic in Arms Regulations (ITAR). Employment is contingent upon the applicant being a "U.S. person" as defined by ITAR (22 CFR 120.15), which includes U.S. citizens, lawful permanent residents, refugees, or asylees, as required by U.S. export control laws. 8am - 5pm
09/25/2026
Full time
Job DescriptionJob Description Bal Seal Engineering is seeking a QC Supervisor to support the Quality Assurance department in overseeing all Quality inspection activity from Receiving Inspection to Shipping Audit as well as supporting interdepartmental projects and studies with Quality Assurance knowledge and resources. The Quality Assurance Supervisor manages the hourly Quality personnel and is their main point of contact for questions and support. About Bal Seal: Bal Seal Engineering delivers advanced sealing, connecting, and contact solutions that serve medical, aerospace, energy, and industrial markets. Our proprietary spring-energized seals and electrical contacts help customers achieve precision, efficiency, and reliability. Employees thrive in a culture that values craftsmanship, technical mastery, and close partnership with customers solving complex challenges. Reports to: QA Manager Department: QA Essential Duties and Responsibilities: Develop, train, direct, coach, counsel, communicate to, monitor, appraise and manage personnel Ensure compliance to all company-wide and Quality Assurance-specific procedures Manage the MRB and Calibration processes Coordinate with Production Control to assist in meeting Production goals and to ensure inspection is completed in a timely manner Manage department to ensure inspection resources are properly allocated Establish performance metrics for inspection personnel and evaluate them accordingly Perform other related duties as assigned Education: Bachelor's Degree in Business, Management, or a STEM field preferred LSS Green Belt preferred Experience: Minimum 5 years in a quality role Leadership experience preferred Knowledge, Skills and Abilities: Strong leadership skills that inspire team with confidence and respect while motivating the members in a creative and effective manner Excellent interpersonal skills Advanced computer skills (i.e. creating and revising procedures, people management software, creating forms, data manipulation) Intermediate software knowledge of Microsoft Office Suite (e.g. email, calendar, creating tables, graphs, performing calculations, using plug-ins) Experience with product lifecycle management software (e.g. Agile) Experience with enterprise resource planning software (e.g. E1) Ability to learn and navigate custom/specialized software Ability to comprehend written instructions with industry-specific terms and technical concepts Familiarity with inspection plans Familiarity with statistical process control (SPC) Ability to use manual gauges (e.g. micrometers, calipers, scales) Intermediate knowledge of visual inspection systems (i.e. Smartscope) Experience with mechanical test equipment (e.g. Chatillon force tester, United tensile tester, surface profilometer) Understanding of a QMS based on ISO 9001/AS9100 requirements Ability to problem solve Basic understanding of statistical methods (AQL, mean, variation, control charts, histograms) Ability to speak, read, and write in English with technical proficiency (required) Ability to speak Spanish (preferred) Physical Requirements: This position is mainly sedentary; Therefore, required to sit Prolonged periods of sitting at a desk and working on a computer While performing the duties of this job, the employee is occasionally required to walk throughout the facility Frequent lifting and/or moving up to 10 pounds and occasionally lifting and/or move up to 25 pounds Occasionally will need to bend, stoop and squat Work Environment: The work environment conditions are typical of a manufacturing environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the basic functions. The noise level in the work environment ranges from quiet to moderate, however, hearing protection may be required if employee enters high noise areas as a part of their normal job duties. Benefits: At Bal Seal Engineering (BSE) we recognize how important your career and benefits are to you and your family. We offer a full suite of benefits, including medical, dental, vision, short and long-term disability coverage, accident insurance, critical illness insurance, basic and supplemental life insurance, employee assistance plan, retirement savings and matching, and other developmental opportunities. We are committed to supporting the way you live and work. BSE is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status. Applicants requiring reasonable accommodation to complete the application process may contact Human Resources. This position requires access to information subject to the International Traffic in Arms Regulations (ITAR). Employment is contingent upon the applicant being a "U.S. person" as defined by ITAR (22 CFR 120.15), which includes U.S. citizens, lawful permanent residents, refugees, or asylees, as required by U.S. export control laws. 8am - 5pm
Job DescriptionJob Description Quality Assurance Specialist Pay Rate: $19.00/hour Schedule: Monday-Friday, 7:30 AM-4:30 PM CT Work Arrangement: Hybrid - Friday only Manager: Britney Important: This is NOT a warehouse position. Warehouse Quality Assurance experience alone does not qualify for this opportunity. The ideal candidate will have professional experience in quality assurance, auditing, call/chat monitoring, performance evaluations, scorecards, or service-quality monitoring. The Quality Assurance Specialist will conduct evaluations, track quality results, identify performance gaps, provide constructive feedback, maintain QA metrics, and partner with management and training teams to improve overall service quality. Key Responsibilities Monitor and evaluate customer/service interactions for compliance with established quality standards. Conduct Quality Assurance evaluations using Microsoft Forms. Review calls, chats, processes, and other interactions using established QA scorecards and guidelines. Track, document, and report QA evaluation results. Communicate evaluation outcomes clearly and professionally. Provide constructive feedback and coaching based on QA findings. Identify performance gaps and partner with management and training teams on improvement opportunities. Maintain accurate quality metrics and supporting documentation. Prepare detailed quality reports for management and stakeholders. Analyze quality trends and identify recurring issues. Recommend actionable solutions to improve processes and service delivery. Support the development and improvement of QA processes, procedures, and guidelines. Ensure evaluations are completed accurately, consistently, and within established deadlines. Manage a high-volume workload while maintaining strong attention to detail. Technical Requirements Candidates should have strong working knowledge of: Microsoft Excel Microsoft 365 Microsoft Outlook Windows 10 Microsoft Forms Data tracking and reporting tools Experience with the following systems is preferred: SAP JDE i5 HighRadius Preferred Experience 2+ years of Quality Assurance, auditing, quality monitoring, or similar experience preferred. Experience monitoring calls, chats, customer interactions, or service processes. Experience completing performance evaluations using QA scorecards. Experience tracking and reporting performance or quality data. Experience delivering professional feedback and coaching. Experience identifying trends, performance gaps, and process-improvement opportunities. Experience working in a high-volume professional environment. Warehouse QA experience by itself does not meet the requirements for this position. Key Skills Exceptional attention to detail Analytical and critical-thinking skills Strong written and verbal communication Professional coaching and feedback skills Data analysis and reporting Time management and organization Ability to manage multiple priorities Problem-solving Collaboration and teamwork Accountability Adaptability Customer-focused mindset Continuous improvement Education Bachelor's degree in Business, Quality Management, or a related field preferred. Relevant professional Quality Assurance experience may also be considered based on the requirements of the position. Ideal Candidate The ideal candidate is someone who can review a high volume of interactions and data while remaining accurate, objective, consistent, and detail-oriented. Candidates should be comfortable identifying quality issues, documenting findings, discussing performance with team members and leadership, and helping improve overall service delivery. Important Candidate Requirement This is not a warehouse or manufacturing Quality Assurance position. Candidates should have QA experience involving areas such as customer service, call/chat monitoring, auditing, scorecards, performance evaluation, compliance, data reporting, or process quality.
09/25/2026
Full time
Job DescriptionJob Description Quality Assurance Specialist Pay Rate: $19.00/hour Schedule: Monday-Friday, 7:30 AM-4:30 PM CT Work Arrangement: Hybrid - Friday only Manager: Britney Important: This is NOT a warehouse position. Warehouse Quality Assurance experience alone does not qualify for this opportunity. The ideal candidate will have professional experience in quality assurance, auditing, call/chat monitoring, performance evaluations, scorecards, or service-quality monitoring. The Quality Assurance Specialist will conduct evaluations, track quality results, identify performance gaps, provide constructive feedback, maintain QA metrics, and partner with management and training teams to improve overall service quality. Key Responsibilities Monitor and evaluate customer/service interactions for compliance with established quality standards. Conduct Quality Assurance evaluations using Microsoft Forms. Review calls, chats, processes, and other interactions using established QA scorecards and guidelines. Track, document, and report QA evaluation results. Communicate evaluation outcomes clearly and professionally. Provide constructive feedback and coaching based on QA findings. Identify performance gaps and partner with management and training teams on improvement opportunities. Maintain accurate quality metrics and supporting documentation. Prepare detailed quality reports for management and stakeholders. Analyze quality trends and identify recurring issues. Recommend actionable solutions to improve processes and service delivery. Support the development and improvement of QA processes, procedures, and guidelines. Ensure evaluations are completed accurately, consistently, and within established deadlines. Manage a high-volume workload while maintaining strong attention to detail. Technical Requirements Candidates should have strong working knowledge of: Microsoft Excel Microsoft 365 Microsoft Outlook Windows 10 Microsoft Forms Data tracking and reporting tools Experience with the following systems is preferred: SAP JDE i5 HighRadius Preferred Experience 2+ years of Quality Assurance, auditing, quality monitoring, or similar experience preferred. Experience monitoring calls, chats, customer interactions, or service processes. Experience completing performance evaluations using QA scorecards. Experience tracking and reporting performance or quality data. Experience delivering professional feedback and coaching. Experience identifying trends, performance gaps, and process-improvement opportunities. Experience working in a high-volume professional environment. Warehouse QA experience by itself does not meet the requirements for this position. Key Skills Exceptional attention to detail Analytical and critical-thinking skills Strong written and verbal communication Professional coaching and feedback skills Data analysis and reporting Time management and organization Ability to manage multiple priorities Problem-solving Collaboration and teamwork Accountability Adaptability Customer-focused mindset Continuous improvement Education Bachelor's degree in Business, Quality Management, or a related field preferred. Relevant professional Quality Assurance experience may also be considered based on the requirements of the position. Ideal Candidate The ideal candidate is someone who can review a high volume of interactions and data while remaining accurate, objective, consistent, and detail-oriented. Candidates should be comfortable identifying quality issues, documenting findings, discussing performance with team members and leadership, and helping improve overall service delivery. Important Candidate Requirement This is not a warehouse or manufacturing Quality Assurance position. Candidates should have QA experience involving areas such as customer service, call/chat monitoring, auditing, scorecards, performance evaluation, compliance, data reporting, or process quality.
Job DescriptionJob Description Location: Waltham, MA & Framingham, MA This role will require full-time on-site presence at our client site in Framingham or Waltham. MA. This role is NOT eligible for relocation assistance The Zifo Lab Computing Analyst provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal Zifo support team. Requirements Required Skills: Excellent customer service skills complemented by an ability to listen to and interpret client requests Ability to troubleshoot complex instrument and technology issues Strong oral and written communication skills Ability to identify, track and complete tasks for multiple projects Knowledge of laboratory safety practices as defined by the company and/or customer's site safety code Responsibilities: As a Lab Computing Analyst, beneficiary would perform following key responsibilities: Requirements Management and onsite Validation/Compliance support IT Consulting Customer Liaison Onsite Lab IT Support Requirements Management Understand problem statement/challenges Define scope Gather requirements. Assist with Validation/Compliance activities (IOPQ) as required. Analyze current state business processes and requirements. Assist in building plans for process improvement IT Consulting Analyze gaps/opportunities for improvement based on industry Best Practice Evaluate Industry trends to identify areas for optimization Evaluate vendor solutions and facilitate demos of prototypes as Proofs of Concept Recommend process improvements that fit business needs Customer Liaison: Meeting with internal/external service groups/leads Liaise between System/Lab owners and third parties to coordinate best times for services Provide weekly planning schedules for review at status meeting with customer leads Monthly Operational review meetings/ Quarterly metrics reporting with department heads On Site Lab IT Support: Perform break/fix support for all Instrument connected systems Implement Windows based security policies as required Ensure adherence to client's corporate policies through periodic reporting & compliance programs Acts as the technical support contact for field service engineers and external vendors Provide technical subject matter expertise for new system validation and change management Create and maintain a physical inventory of lab equipment, PC's, software, and any other information pertinent to the environment if applicable Perform system preventative maintenances based on client's schedule, if applicable Requirements Bachelor's/Master's degree or equivalent in Pharmaceutical, Bio-technology, Bio-medical, Chemical 3+ years of relevant technical experience including (but not limited to); Windows technologies, networking, remote computing and backup systems At least 1 year in software development and testing. At least 1 year of experience in business requirement analysis and gathering. Demonstrated domain area knowledge. Candidate must possess excellent analytical and interpersonal skills along with a proven track record in system design, implementation, have demonstrated ability to guide the activities of colleagues, and have demonstrated ability to gain client's confidence and trust. Candidate must demonstrate in-depth understanding in one or more of the following areas of Bio/Pharma industry: Drug Discovery & Development Processes Clinical study planning & Data management Lab Workflows Chemical & Biologics material Management Sample Management Robotic Systems Integration & Qualification Operations KPI and Metrics tracking Optional requirement: Candidate needs to be familiar with the US and International Regulations and Standards governing the development of technical solutions such as GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820 Technical Skills: Operating System familiarity with at least 1 of the following: Unix, Windows, MVS Software Methodology familiarity with: Object Oriented Programming, Structured Programming Software Development Process familiarity with: Waterfall, Agile Change Control Management and Risk Management Office Tools proficiency required in : MS Word, Excel, PowerPoint Office productivity tool proficiency in at least 1 of the following: Visio, MS Project, SharePoint Benefits About Zifo: CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team's knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies. We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a "no doors" policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda - technical competency and cultural adaptability. We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts. If you share these sentiments and are prepared for the atypical, then Zifo is your calling! Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
09/25/2026
Full time
Job DescriptionJob Description Location: Waltham, MA & Framingham, MA This role will require full-time on-site presence at our client site in Framingham or Waltham. MA. This role is NOT eligible for relocation assistance The Zifo Lab Computing Analyst provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal Zifo support team. Requirements Required Skills: Excellent customer service skills complemented by an ability to listen to and interpret client requests Ability to troubleshoot complex instrument and technology issues Strong oral and written communication skills Ability to identify, track and complete tasks for multiple projects Knowledge of laboratory safety practices as defined by the company and/or customer's site safety code Responsibilities: As a Lab Computing Analyst, beneficiary would perform following key responsibilities: Requirements Management and onsite Validation/Compliance support IT Consulting Customer Liaison Onsite Lab IT Support Requirements Management Understand problem statement/challenges Define scope Gather requirements. Assist with Validation/Compliance activities (IOPQ) as required. Analyze current state business processes and requirements. Assist in building plans for process improvement IT Consulting Analyze gaps/opportunities for improvement based on industry Best Practice Evaluate Industry trends to identify areas for optimization Evaluate vendor solutions and facilitate demos of prototypes as Proofs of Concept Recommend process improvements that fit business needs Customer Liaison: Meeting with internal/external service groups/leads Liaise between System/Lab owners and third parties to coordinate best times for services Provide weekly planning schedules for review at status meeting with customer leads Monthly Operational review meetings/ Quarterly metrics reporting with department heads On Site Lab IT Support: Perform break/fix support for all Instrument connected systems Implement Windows based security policies as required Ensure adherence to client's corporate policies through periodic reporting & compliance programs Acts as the technical support contact for field service engineers and external vendors Provide technical subject matter expertise for new system validation and change management Create and maintain a physical inventory of lab equipment, PC's, software, and any other information pertinent to the environment if applicable Perform system preventative maintenances based on client's schedule, if applicable Requirements Bachelor's/Master's degree or equivalent in Pharmaceutical, Bio-technology, Bio-medical, Chemical 3+ years of relevant technical experience including (but not limited to); Windows technologies, networking, remote computing and backup systems At least 1 year in software development and testing. At least 1 year of experience in business requirement analysis and gathering. Demonstrated domain area knowledge. Candidate must possess excellent analytical and interpersonal skills along with a proven track record in system design, implementation, have demonstrated ability to guide the activities of colleagues, and have demonstrated ability to gain client's confidence and trust. Candidate must demonstrate in-depth understanding in one or more of the following areas of Bio/Pharma industry: Drug Discovery & Development Processes Clinical study planning & Data management Lab Workflows Chemical & Biologics material Management Sample Management Robotic Systems Integration & Qualification Operations KPI and Metrics tracking Optional requirement: Candidate needs to be familiar with the US and International Regulations and Standards governing the development of technical solutions such as GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820 Technical Skills: Operating System familiarity with at least 1 of the following: Unix, Windows, MVS Software Methodology familiarity with: Object Oriented Programming, Structured Programming Software Development Process familiarity with: Waterfall, Agile Change Control Management and Risk Management Office Tools proficiency required in : MS Word, Excel, PowerPoint Office productivity tool proficiency in at least 1 of the following: Visio, MS Project, SharePoint Benefits About Zifo: CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team's knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies. We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a "no doors" policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda - technical competency and cultural adaptability. We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts. If you share these sentiments and are prepared for the atypical, then Zifo is your calling! Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Job DescriptionJob Description OVERVIEW We are seeking Quality Assurance Specialists with varying levels of experience to join Hendall Inc. These roles will focus conducting software development quality assurance activities including integration testing, system testing, regression testing, performance testing and acceptance testing. These individuals will work closely with other Quality Assurance Specialists, Business Analyst(s), Software Developer(s) and Project Leads to define, document and test all business and technical requirements necessary to satisfy product owner's needs. They will also work with the software development team and project management to help manage scope of sprints and releases. The Quality Assurance Specialist will support project risk management activities to ensure all deliverables are delivered with consistently high quality with minimum defects. DUTIES Support all quality assurance activities Review and analyze system specifications Develop effective strategies and test plans Execute test cases (manual or automated) and analyze results Evaluate product code according to specifications Create logs to document testing phases and defects Report bugs and errors to development teams Help troubleshoot issues Conduct post-release/ post-implementation testing Work with cross-functional teams to ensure quality throughout the software development lifecycle Ensure compliance with all federal accessibility standards and guidelines Identify and manage project risks Provide documentation in the form of Test Management Plans, Test Cases and Test Reports throughout the complete software development lifecycle Perform other duties as assigned by supervisor or manager MINIMUM QUALIFICATIONS At least 3-8 years of experience in quality assurance and application testing Working knowledge of at least one Section 508 compliance tools (JAWS preferably) Experience using JIRA Defect Management Tool Demonstrated experience in creating and executing test scripts, and communicating results to management Strong verbal and written communication skills Highly organized and detail oriented Flexible, versatile, and works well under pressure Bachelor's Degree in Computer Science, Engineering, related IT field of equivalent experience PREFERRED QUALIFICATIONS Experience performing backend database testing Experience using automated test tools (Selenium, JMeter, Python Testing Frameworks) is a plus Experience with Capability Maturity Model Integration (CMMI) Strong sense of urgency and ability to prioritize Experience in software development Salary Range: $85,000/year to $125,000/year For a complete listing of benefits, please visit our careers page at Hendall Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
09/25/2026
Full time
Job DescriptionJob Description OVERVIEW We are seeking Quality Assurance Specialists with varying levels of experience to join Hendall Inc. These roles will focus conducting software development quality assurance activities including integration testing, system testing, regression testing, performance testing and acceptance testing. These individuals will work closely with other Quality Assurance Specialists, Business Analyst(s), Software Developer(s) and Project Leads to define, document and test all business and technical requirements necessary to satisfy product owner's needs. They will also work with the software development team and project management to help manage scope of sprints and releases. The Quality Assurance Specialist will support project risk management activities to ensure all deliverables are delivered with consistently high quality with minimum defects. DUTIES Support all quality assurance activities Review and analyze system specifications Develop effective strategies and test plans Execute test cases (manual or automated) and analyze results Evaluate product code according to specifications Create logs to document testing phases and defects Report bugs and errors to development teams Help troubleshoot issues Conduct post-release/ post-implementation testing Work with cross-functional teams to ensure quality throughout the software development lifecycle Ensure compliance with all federal accessibility standards and guidelines Identify and manage project risks Provide documentation in the form of Test Management Plans, Test Cases and Test Reports throughout the complete software development lifecycle Perform other duties as assigned by supervisor or manager MINIMUM QUALIFICATIONS At least 3-8 years of experience in quality assurance and application testing Working knowledge of at least one Section 508 compliance tools (JAWS preferably) Experience using JIRA Defect Management Tool Demonstrated experience in creating and executing test scripts, and communicating results to management Strong verbal and written communication skills Highly organized and detail oriented Flexible, versatile, and works well under pressure Bachelor's Degree in Computer Science, Engineering, related IT field of equivalent experience PREFERRED QUALIFICATIONS Experience performing backend database testing Experience using automated test tools (Selenium, JMeter, Python Testing Frameworks) is a plus Experience with Capability Maturity Model Integration (CMMI) Strong sense of urgency and ability to prioritize Experience in software development Salary Range: $85,000/year to $125,000/year For a complete listing of benefits, please visit our careers page at Hendall Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Job DescriptionJob DescriptionCompany Description With over $2B in revenue, 80+ manufacturing facilities across 6 continents and over 9,000 employees worldwide, Signode is a leading manufacturer of a broad spectrum of transit packaging consumables, tools, software, and equipment that optimize end-of-line packaging operations and protect products in transit. Signode brings this extensive product portfolio together under hundreds of trusted brands to offer complete transit packaging solutions to its customers. We produce strap, stretch and protective packaging. We also manufacture packaging tools and equipment used to apply the bulk packaging materials. These commercial packaging products are used to pack, bundle, unitize, protect, and secure goods during warehousing and transit. Our company is a pioneer in the industrial packaging sector with a long history of customer-focused innovations in materials, processes and automation technology that have revolutionized the sector. Headquartered in Tampa, Florida, we are proud to be the Transit Packaging Division of Crown Holdings, Inc. We are excited to go to market as Signode and to share the portfolio of products, services and capabilities that make us the world's premier end-of-line packaging company. Job Description Benefits: Signode offers a comprehensive benefits package to full-time employees, which includes health, dental, vision, 401k, paid time off, life insurance, wellness perks, and more. Benefits begin the month following the hire date. Salary: The annual salary for this position ranges from $127,000 - $152,000 + 10% bonus target and varies based on specific responsibilities and geographic location. Starting annual salary within this range will be determined based on the candidate's experience, qualifications, and/or skillset. Summary We are seeking a highly experienced and versatile Manager, Application Delivery & QA to lead IT application delivery and quality assurance across our enterprise and local application portfolio. This role is accountable for application delivery, quality governance, testing strategy, test automation, and execution across enterprise application initiatives. The position combines App Delivery management with hands-on QA leadership to ensure projects are delivered with strong testing discipline, business readiness, SOX compliance, and measurable quality outcomes. This role supports a diverse application portfolio that includes major enterprise platforms such as Microsoft Dynamics 365 Finance & Operations, Dynamics 365 Customer Engagement (CE), AX 2012, third-party applications, custom-developed solutions, and system integrations. The successful candidate will serve as a key liaison between business stakeholders and different IT teams to drive high-quality project delivery. This position is well suited for an experienced IT leader who can effectively balance multiple priorities while operating across quality assurance, application delivery, project governance, stakeholder management, and organizational change management. Essential Functions Technical Project Management & Agile Delivery Lead IT application projects from initiation through deployment Manage project scope, timelines, budgets, risks, dependencies, and resource planning Facilitate Agile ceremonies including Sprint Planning, Daily Standups, Backlog Grooming, Sprint Reviews, Retrospectives Partner with business stakeholders to define priorities and roadmap objectives Translate business requirements into actionable user stories and technical work items Coordinate development, QA, infrastructure, and business teams to ensure successful delivery Track project progress and communicate status, risks, and mitigation plans to leadership Manage relationships with implementation partners and third-party vendors Quality Assurance & Testing Leadership Establish and maintain Enterprise Apps testing standards, methodologies, and governance processes adhering to SOX compliance for the Global projects with a major focus on Global ERP rollout Use an AI-first approach and look for ways to utilize AI to streamline delivery of QA, App Delivery, and Projects Work with matrix internal IT teams and end users, Lead SIT, UAT, regression, integration, and release testing activities Develop and oversee comprehensive test strategies and test plans Create and review test scenarios, test scripts, and business process validation documents Manage defect lifecycle processes and defect triage activities Ensure appropriate testing coverage for Finance, Manufacturing, Supply Chain, Procurement, Inventory, and Order Management processes Drive continuous improvement of testing practices and quality metrics Conduct go-live assessment and testing sign-offs working hand in hand with business teams as well as the compliance team. Support apps other than ERP for testing and sign-off process Manage test planning and execution using Azure DevOps Create and maintain: Test Plans, Test Suites, User Stories, Defect Tracking, Requirements Traceability Drive adoption of ERP test automation solutions, preferably Test Mart Develop automated regression testing strategies and improve test efficiency Build KPI dashboards to monitor testing quality, defect trends, and release readiness Document and communicate Test cases, SOPs, and changes to business stakeholders. Team Leadership Provide leadership, mentoring, and coaching to QA and support team members. Allocate workload and ensure resource optimization across projects and support functions. Establish performance objectives and development plans for team members. Promote quality, accountability, and continuous improvement within the team. Qualifications Education: A bachelor's degree in computer science, data science, Information Technology, or an engineering field, or at least nine (9) years of professional experience in a similar technology role Experience: 7 - 9 years of experience working as an IT Delivery Manager or QA Manager. In addition: Minimum 7+ years of experience in ERP QA execution and delivery and IT apps project delivery 6+ years of experience conducting UAT for large-scale global ERP projects, minimum 2 5+ years of experience leading technical projects as a scrum master or technical PM Experience leading small technical or QA teams Strong functional/technical experience with: Microsoft Dynamics 365 Finance & Operations, CE Microsoft Dynamics AX 2012 Experience supporting enterprise ERP environments and Other Apps, including CRM, within manufacturing, distribution, or supply chain-focused organizations 6+ years of experience managing Azure DevOps and testing documentation and plans 5+ years of experience with Testing automation software, with 3+ years working with TestMart to develop test suite automation 5+ years of config and admin experience of ITSM tools like Freshworks or ServiceNow 3+ years of experience working with Azure Industry experience working in a technical environment, preferably in manufacturing An ability to manage multiple complex projects concurrently and autonomously A high aptitude for QA leadership for global ERP rollouts Ability to influence decision-making processes and foster an environment of healthy team debate Strong risk awareness and the ability to identify imminent risks Strong communication and presentation skills Experience leading global teams in a matrix environment Functional Success Drivers: These competencies are what we require for an individual to be successful in this role: Leadership Communication Strategic Skills Excellence Results-Oriented Leading Edge Additional Information All your information will be kept confidential according to EEO guidelines. The Company does not sponsor for employment-based visas for this position now or in the future. Reasonable Accommodation Statement To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities. Signode is committed to providing equal opportunities to all qualified applicants, including providing reasonable accommodations during our recruiting process. If you need any assistance or accommodation in applying for this position, please contact us at . The Company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the Company reserves the right to change this job description and/or assign tasks for the employee to perform, as the Company may deem appropriate. Signode participates in E-Verify and will provide the Department of Homeland Security your Form I-9 information to confirm your authorization to work in the United States. . click apply for full job details
09/25/2026
Full time
Job DescriptionJob DescriptionCompany Description With over $2B in revenue, 80+ manufacturing facilities across 6 continents and over 9,000 employees worldwide, Signode is a leading manufacturer of a broad spectrum of transit packaging consumables, tools, software, and equipment that optimize end-of-line packaging operations and protect products in transit. Signode brings this extensive product portfolio together under hundreds of trusted brands to offer complete transit packaging solutions to its customers. We produce strap, stretch and protective packaging. We also manufacture packaging tools and equipment used to apply the bulk packaging materials. These commercial packaging products are used to pack, bundle, unitize, protect, and secure goods during warehousing and transit. Our company is a pioneer in the industrial packaging sector with a long history of customer-focused innovations in materials, processes and automation technology that have revolutionized the sector. Headquartered in Tampa, Florida, we are proud to be the Transit Packaging Division of Crown Holdings, Inc. We are excited to go to market as Signode and to share the portfolio of products, services and capabilities that make us the world's premier end-of-line packaging company. Job Description Benefits: Signode offers a comprehensive benefits package to full-time employees, which includes health, dental, vision, 401k, paid time off, life insurance, wellness perks, and more. Benefits begin the month following the hire date. Salary: The annual salary for this position ranges from $127,000 - $152,000 + 10% bonus target and varies based on specific responsibilities and geographic location. Starting annual salary within this range will be determined based on the candidate's experience, qualifications, and/or skillset. Summary We are seeking a highly experienced and versatile Manager, Application Delivery & QA to lead IT application delivery and quality assurance across our enterprise and local application portfolio. This role is accountable for application delivery, quality governance, testing strategy, test automation, and execution across enterprise application initiatives. The position combines App Delivery management with hands-on QA leadership to ensure projects are delivered with strong testing discipline, business readiness, SOX compliance, and measurable quality outcomes. This role supports a diverse application portfolio that includes major enterprise platforms such as Microsoft Dynamics 365 Finance & Operations, Dynamics 365 Customer Engagement (CE), AX 2012, third-party applications, custom-developed solutions, and system integrations. The successful candidate will serve as a key liaison between business stakeholders and different IT teams to drive high-quality project delivery. This position is well suited for an experienced IT leader who can effectively balance multiple priorities while operating across quality assurance, application delivery, project governance, stakeholder management, and organizational change management. Essential Functions Technical Project Management & Agile Delivery Lead IT application projects from initiation through deployment Manage project scope, timelines, budgets, risks, dependencies, and resource planning Facilitate Agile ceremonies including Sprint Planning, Daily Standups, Backlog Grooming, Sprint Reviews, Retrospectives Partner with business stakeholders to define priorities and roadmap objectives Translate business requirements into actionable user stories and technical work items Coordinate development, QA, infrastructure, and business teams to ensure successful delivery Track project progress and communicate status, risks, and mitigation plans to leadership Manage relationships with implementation partners and third-party vendors Quality Assurance & Testing Leadership Establish and maintain Enterprise Apps testing standards, methodologies, and governance processes adhering to SOX compliance for the Global projects with a major focus on Global ERP rollout Use an AI-first approach and look for ways to utilize AI to streamline delivery of QA, App Delivery, and Projects Work with matrix internal IT teams and end users, Lead SIT, UAT, regression, integration, and release testing activities Develop and oversee comprehensive test strategies and test plans Create and review test scenarios, test scripts, and business process validation documents Manage defect lifecycle processes and defect triage activities Ensure appropriate testing coverage for Finance, Manufacturing, Supply Chain, Procurement, Inventory, and Order Management processes Drive continuous improvement of testing practices and quality metrics Conduct go-live assessment and testing sign-offs working hand in hand with business teams as well as the compliance team. Support apps other than ERP for testing and sign-off process Manage test planning and execution using Azure DevOps Create and maintain: Test Plans, Test Suites, User Stories, Defect Tracking, Requirements Traceability Drive adoption of ERP test automation solutions, preferably Test Mart Develop automated regression testing strategies and improve test efficiency Build KPI dashboards to monitor testing quality, defect trends, and release readiness Document and communicate Test cases, SOPs, and changes to business stakeholders. Team Leadership Provide leadership, mentoring, and coaching to QA and support team members. Allocate workload and ensure resource optimization across projects and support functions. Establish performance objectives and development plans for team members. Promote quality, accountability, and continuous improvement within the team. Qualifications Education: A bachelor's degree in computer science, data science, Information Technology, or an engineering field, or at least nine (9) years of professional experience in a similar technology role Experience: 7 - 9 years of experience working as an IT Delivery Manager or QA Manager. In addition: Minimum 7+ years of experience in ERP QA execution and delivery and IT apps project delivery 6+ years of experience conducting UAT for large-scale global ERP projects, minimum 2 5+ years of experience leading technical projects as a scrum master or technical PM Experience leading small technical or QA teams Strong functional/technical experience with: Microsoft Dynamics 365 Finance & Operations, CE Microsoft Dynamics AX 2012 Experience supporting enterprise ERP environments and Other Apps, including CRM, within manufacturing, distribution, or supply chain-focused organizations 6+ years of experience managing Azure DevOps and testing documentation and plans 5+ years of experience with Testing automation software, with 3+ years working with TestMart to develop test suite automation 5+ years of config and admin experience of ITSM tools like Freshworks or ServiceNow 3+ years of experience working with Azure Industry experience working in a technical environment, preferably in manufacturing An ability to manage multiple complex projects concurrently and autonomously A high aptitude for QA leadership for global ERP rollouts Ability to influence decision-making processes and foster an environment of healthy team debate Strong risk awareness and the ability to identify imminent risks Strong communication and presentation skills Experience leading global teams in a matrix environment Functional Success Drivers: These competencies are what we require for an individual to be successful in this role: Leadership Communication Strategic Skills Excellence Results-Oriented Leading Edge Additional Information All your information will be kept confidential according to EEO guidelines. The Company does not sponsor for employment-based visas for this position now or in the future. Reasonable Accommodation Statement To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities. Signode is committed to providing equal opportunities to all qualified applicants, including providing reasonable accommodations during our recruiting process. If you need any assistance or accommodation in applying for this position, please contact us at . The Company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the Company reserves the right to change this job description and/or assign tasks for the employee to perform, as the Company may deem appropriate. Signode participates in E-Verify and will provide the Department of Homeland Security your Form I-9 information to confirm your authorization to work in the United States. . click apply for full job details
Job DescriptionJob Description At AmaWaterways, we believe meaningful careers begin with purpose, passion and a shared commitment to delivering unforgettable experiences. For those who value curiosity, connection and personal enrichment, AmaWaterways offers the opportunity to help craft meaningful river journeys that invite travelers to follow their own current. Built on a foundation of heartfelt hospitality, we treat our guests-and each other-with genuine care, warmth and respect. AmaWaterways fosters a collaborative environment both onboard our ships and across our global network of offices, where team members grow together, support one another and take pride in upholding the high standards and thoughtful service our company is known for. We invite talented, motivated professionals to explore our career opportunities and begin their journey with AmaWaterways today. This position is primarily responsible for leading and growing the quality assurance function across the company's web platform, APIs, integrations, and supporting services. The QA Manager owns the overall QA strategy, standards, and processes; manages and develops the QA team; and partners with engineering, product, and DevOps to ensure releases are predictable, reliable, and delivered with confidence. DUTIES AND RESPONSIBILITIES: Defines, owns, and continuously improves the end-to-end QA strategy across web, mobile-web, backend services, and integrations. Leads, mentors, and grows a team of QA specialists, automation engineers, and SDETs, fostering a culture of quality and accountability. Establishes and maintains QA standards, test plans, regression suites, smoke-test procedures, and release sign-off processes. Champions shift-left testing and embeds quality practices across the engineering organization. Identifies critical user journeys and high-risk areas, ensuring appropriate test coverage at each layer of the test pyramid. Sets the direction for automation frameworks across UI, API, and integration testing, and ensures suites are robust, maintainable, and trusted. Oversees integration of automated tests into CI/CD pipelines, and defines quality gates, deployment criteria, and rollback triggers in collaboration with DevOps. Owns release readiness and sign-off, ensuring consistent, repeatable, and low-risk deployments across Dev, QA, UAT, and Production. Defines, tracks, and reports on key quality metrics such as defect leakage, escape rate, test coverage, flakiness, MTTD, and MTTR. Provides clear, regular quality reporting and risk assessments to engineering leadership and business stakeholders. Manages relationships with external QA vendors and tooling providers, and contributes to build-versus-buy decisions. Analyzes production incidents to identify gaps in coverage and process, and drives corrective and preventive actions. Establishes and maintains quality governance, including audit readiness, compliance, and data-handling considerations relevant to the business. Evaluates and introduces new tools, technologies, and methodologies to advance the QA function. Provides project effort estimations and resource planning for QA activities across competing priorities. Communicates effectively with technical and non-technical groups, both internally and externally. Maintains current knowledge of relevant technology and quality engineering practices, as assigned. Participates in special projects, as required. Performs other related duties as assigned by management. SUPERVISORY RESPONSIBILITIES: This job carries out supervisory responsibilities in accordance with the organization's policies and applicable laws: Provides day-to-day leadership, mentorship, and technical direction to QA team members. Leads interviewing, evaluation, and hiring of QA specialists, automation engineers, and SDETs. Owns onboarding and training to ensure adherence to quality standards and best practices. Assigns work, monitors progress, and ensures timely delivery of testing and release activities. Conducts performance discussions, sets goals, and supports the professional development of team members. Manages capacity and resource allocation across projects, releases, and competing priorities. Addresses workplace or project-related concerns and escalates issues when appropriate. QUALIFICATIONS: Bachelor's Degree (BA/BS) from a four-year college or university, or seven or more years of related experience and/or training, or an equivalent combination of education and experience. Seven or more years of professional QA experience, with at least three years in a lead or management capacity. Proven track record of building, leading, and scaling QA teams and functions. Computer skills required: Microsoft Office Suite; Project Management Software; Test Management and Defect Tracking Software (e.g., Jira); Database Software; Development Software; Internet Software; Spreadsheet Software; Word Processing Software; Electronic Mail Software; Presentation Software. Other skills required: Strong technical foundation in test automation, with hands-on experience in UI automation (Playwright, Cypress, or Selenium) and API testing tools (Postman/Newman, REST Assured, or Pact). Experience defining QA strategy and embedding quality practices across engineering organizations. Solid understanding of CI/CD pipelines and integrating automated testing into delivery workflows (Azure DevOps, GitHub Actions, Jenkins, or similar). Strong grasp of testing methodologies: TDD, BDD, the test pyramid, risk-based testing, and exploratory testing. Solid understanding of REST APIs, HTTP, authentication mechanisms (OAuth, JWT), and API contract testing. Experience with version control (Git) and code review practices. Strong experience with relational databases and writing SQL queries for data validation and analysis. Demonstrated people-management skills: hiring, mentoring, performance management, and resource planning. Cloud, DevOps, and CI/CD: Familiarity with cloud platforms (preferably Microsoft Azure), including app hosting, storage, networking, and security concepts. Experience embedding automated build, test, and deployment quality gates across multiple environments (Dev, QA, UAT, Prod). Experience with application monitoring, logging, and alerting in cloud environments (e.g., Datadog, New Relic, Grafana, Sentry). Performance and load testing experience with k6, JMeter, or Gatling is a plus. Security Methodology: Knowledge of secure coding and application security principles (e.g., OWASP Top 10) and security testing fundamentals. Experience working in Agile/Scrum environments; Scrum Master experience is a plus. ISTQB Advanced Level certification, or other relevant quality/leadership certification, is a plus. Experience managing QA in travel, hospitality, or other data-sensitive industries is a plus. Additional Leadership Expectations: Strong problem-solving and analytical skills. Ability to provide technical leadership and mentor team members. Excellent communication skills and the ability to collaborate with and influence cross-functional teams. Ability to balance multiple priorities and deliver high-quality outcomes on time. COMPETENCIES: Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments. Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget. PHYSICAL DEMANDS AND WORK ENVIRONMENT: Occasionally required to stand Occasionally required to walk Continually required to sit Continually required to utilize hand and finger dexterity Frequently required to talk or hear While performing the duties of this job, the noise level in the work environment is usually moderate The employee must occasionally lift and/or move up to 10 pounds Specific vision abilities required by this job include: Close Vision
09/25/2026
Full time
Job DescriptionJob Description At AmaWaterways, we believe meaningful careers begin with purpose, passion and a shared commitment to delivering unforgettable experiences. For those who value curiosity, connection and personal enrichment, AmaWaterways offers the opportunity to help craft meaningful river journeys that invite travelers to follow their own current. Built on a foundation of heartfelt hospitality, we treat our guests-and each other-with genuine care, warmth and respect. AmaWaterways fosters a collaborative environment both onboard our ships and across our global network of offices, where team members grow together, support one another and take pride in upholding the high standards and thoughtful service our company is known for. We invite talented, motivated professionals to explore our career opportunities and begin their journey with AmaWaterways today. This position is primarily responsible for leading and growing the quality assurance function across the company's web platform, APIs, integrations, and supporting services. The QA Manager owns the overall QA strategy, standards, and processes; manages and develops the QA team; and partners with engineering, product, and DevOps to ensure releases are predictable, reliable, and delivered with confidence. DUTIES AND RESPONSIBILITIES: Defines, owns, and continuously improves the end-to-end QA strategy across web, mobile-web, backend services, and integrations. Leads, mentors, and grows a team of QA specialists, automation engineers, and SDETs, fostering a culture of quality and accountability. Establishes and maintains QA standards, test plans, regression suites, smoke-test procedures, and release sign-off processes. Champions shift-left testing and embeds quality practices across the engineering organization. Identifies critical user journeys and high-risk areas, ensuring appropriate test coverage at each layer of the test pyramid. Sets the direction for automation frameworks across UI, API, and integration testing, and ensures suites are robust, maintainable, and trusted. Oversees integration of automated tests into CI/CD pipelines, and defines quality gates, deployment criteria, and rollback triggers in collaboration with DevOps. Owns release readiness and sign-off, ensuring consistent, repeatable, and low-risk deployments across Dev, QA, UAT, and Production. Defines, tracks, and reports on key quality metrics such as defect leakage, escape rate, test coverage, flakiness, MTTD, and MTTR. Provides clear, regular quality reporting and risk assessments to engineering leadership and business stakeholders. Manages relationships with external QA vendors and tooling providers, and contributes to build-versus-buy decisions. Analyzes production incidents to identify gaps in coverage and process, and drives corrective and preventive actions. Establishes and maintains quality governance, including audit readiness, compliance, and data-handling considerations relevant to the business. Evaluates and introduces new tools, technologies, and methodologies to advance the QA function. Provides project effort estimations and resource planning for QA activities across competing priorities. Communicates effectively with technical and non-technical groups, both internally and externally. Maintains current knowledge of relevant technology and quality engineering practices, as assigned. Participates in special projects, as required. Performs other related duties as assigned by management. SUPERVISORY RESPONSIBILITIES: This job carries out supervisory responsibilities in accordance with the organization's policies and applicable laws: Provides day-to-day leadership, mentorship, and technical direction to QA team members. Leads interviewing, evaluation, and hiring of QA specialists, automation engineers, and SDETs. Owns onboarding and training to ensure adherence to quality standards and best practices. Assigns work, monitors progress, and ensures timely delivery of testing and release activities. Conducts performance discussions, sets goals, and supports the professional development of team members. Manages capacity and resource allocation across projects, releases, and competing priorities. Addresses workplace or project-related concerns and escalates issues when appropriate. QUALIFICATIONS: Bachelor's Degree (BA/BS) from a four-year college or university, or seven or more years of related experience and/or training, or an equivalent combination of education and experience. Seven or more years of professional QA experience, with at least three years in a lead or management capacity. Proven track record of building, leading, and scaling QA teams and functions. Computer skills required: Microsoft Office Suite; Project Management Software; Test Management and Defect Tracking Software (e.g., Jira); Database Software; Development Software; Internet Software; Spreadsheet Software; Word Processing Software; Electronic Mail Software; Presentation Software. Other skills required: Strong technical foundation in test automation, with hands-on experience in UI automation (Playwright, Cypress, or Selenium) and API testing tools (Postman/Newman, REST Assured, or Pact). Experience defining QA strategy and embedding quality practices across engineering organizations. Solid understanding of CI/CD pipelines and integrating automated testing into delivery workflows (Azure DevOps, GitHub Actions, Jenkins, or similar). Strong grasp of testing methodologies: TDD, BDD, the test pyramid, risk-based testing, and exploratory testing. Solid understanding of REST APIs, HTTP, authentication mechanisms (OAuth, JWT), and API contract testing. Experience with version control (Git) and code review practices. Strong experience with relational databases and writing SQL queries for data validation and analysis. Demonstrated people-management skills: hiring, mentoring, performance management, and resource planning. Cloud, DevOps, and CI/CD: Familiarity with cloud platforms (preferably Microsoft Azure), including app hosting, storage, networking, and security concepts. Experience embedding automated build, test, and deployment quality gates across multiple environments (Dev, QA, UAT, Prod). Experience with application monitoring, logging, and alerting in cloud environments (e.g., Datadog, New Relic, Grafana, Sentry). Performance and load testing experience with k6, JMeter, or Gatling is a plus. Security Methodology: Knowledge of secure coding and application security principles (e.g., OWASP Top 10) and security testing fundamentals. Experience working in Agile/Scrum environments; Scrum Master experience is a plus. ISTQB Advanced Level certification, or other relevant quality/leadership certification, is a plus. Experience managing QA in travel, hospitality, or other data-sensitive industries is a plus. Additional Leadership Expectations: Strong problem-solving and analytical skills. Ability to provide technical leadership and mentor team members. Excellent communication skills and the ability to collaborate with and influence cross-functional teams. Ability to balance multiple priorities and deliver high-quality outcomes on time. COMPETENCIES: Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments. Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget. PHYSICAL DEMANDS AND WORK ENVIRONMENT: Occasionally required to stand Occasionally required to walk Continually required to sit Continually required to utilize hand and finger dexterity Frequently required to talk or hear While performing the duties of this job, the noise level in the work environment is usually moderate The employee must occasionally lift and/or move up to 10 pounds Specific vision abilities required by this job include: Close Vision
Job DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS BA/BS Degree in a Scientific or Engineering discipline 8 + years experience computerized system experience with IT compliance/validation/qualification activities. 8 + years experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 10% travel required. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
09/25/2026
Full time
Job DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS BA/BS Degree in a Scientific or Engineering discipline 8 + years experience computerized system experience with IT compliance/validation/qualification activities. 8 + years experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 10% travel required. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Job DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS BA/BS Degree in a Scientific or Engineering discipline 8 + years experience computerized system experience with IT compliance/validation/qualification activities. 8 + years experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 10% travel required. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
09/25/2026
Full time
Job DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS BA/BS Degree in a Scientific or Engineering discipline 8 + years experience computerized system experience with IT compliance/validation/qualification activities. 8 + years experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 10% travel required. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Job DescriptionJob Description Position Summary Description The Manager of NERC Compliance oversees a staff of professionals supporting the administrative aspects of Seminole's North American Electric Reliability Corporation (NERC) and Federal Energy Regulatory Commission (FERC) Standards of Conduct compliance programs. This role manages development, implementation, and monitoring efforts toward ensuring compliance of the various operational business areas with all applicable NERC Standards. Collaborates with Seminole leadership, business areas, NERC and regional regulatory agencies on compliance matters. Accountable for spearheading systematic and continuous improvement of the NERC compliance program, its policies, procedures, training materials, and asset lists. Maintains knowledge of current and future regulatory requirements and assesses their impact to the organization. Essential Functions Provides oversight related to compliance with NERC Reliability Standards and FERC Standards of Conduct. Provides oversight during all compliance monitoring functions including on-site audits, spot checks, and self-certifications Collaborates with leadership and business areas to identify and address potential areas of non-compliance and initiate future compliance requirements. Monitors industry best practices and identifies changes in regulatory compliance for cyber and physical security. Provides oversight on compliance assessments, and ensures corrective action is performed to achieve compliance with NERC Reliability Standards. Provides oversight to communication with regional regulatory agencies and internal departments to ensure compliance issues are addressed in a timely manner. Provides oversight of mandatory filings for federal, state, and local regulatory agencies. Represents organization at meetings at the regional and federal level Interprets new and existing NERC regulations in consultation with legal and other subject matter experts to determine applicability. Provides technical leadership in the planning, development, organizational, coordination, implementation, and review of the NERC compliance program. Leads team of personnel in the performance of NERC compliance audits, surveillances, and assessments and is accountable for urgency, accuracy, and overall quality of program. Participates in industry forums and committees to improve overall compliance with NERC and FERC requirements Participates in the NERC Standards Development Process as necessary to ensure Seminole's interests are addressed when existing standards are revised or new standards are proposed. Performs NERC Compliance Program roles if/as designated in Seminole's Standard Ownership Matrix (SOM) including ongoing evidence retention in "audit-ready" form as applicable and directed. You should also be familiar with Seminole's Enterprise Internal Compliance Program (ENT-GCD-RGC-EP-054) to further your understanding of Seminole's compliance program and the context of your duties and responsibilities attendant to your designation in the SOM. Performs other duties as applicable to the position or as assigned. Qualifications and Education Requirements Bachelor's degree in Computer Science, Information Science, Cyber Security, Electrical Engineering, Business Administration, Business Process Management, Auditing, Risk Management. Alternative degrees in combination with specialized experience and/or certifications may be considered. Master's degree or other advance degree preferred. Desire eight (8) years' experience in a combination of the following: NERC Compliance. Information Technology (IT), Cyber Security or comparable experience with emphasis on technical and security domains. Auditing or Risk Management. Electric Utilities experience subject to NERC Standards. Previous supervisory experience preferred Core Competencies: Adaptable, Collaborative, Conscientious, Critical-Thinking, Outcome-Driven and Professional Technical Competencies/Skills: Demonstrated experience: NERC Reliability Standards Program governance, auditing, and risk management Change management, incident reporting and response planning Process lifecycle and improvement plans Enterprise cyber security principles in context of NERC program Transmission, Generation, Distribution, and/or Energy Management Systems Proficiency with Microsoft Office applications Soft Competencies/Skills: Effective verbal/nonverbal, listening and written communications Effective supervision, performance management and talent development Demonstrated: Hands-on design, management, implementation and operationalization of NERC requirements Practical experience of NERC Rules of Procedure and Compliance Monitoring & Enforcement Program Leadership and delivery of high-quality policies and procedures to support effective regulatory compliance Experience of IT/Cyber Security controls (e.g. engineering, architecture, applications, projects) Experience managing departmental budgets, reporting, and management of direct, indirect, and outside resources Effective relationship management with Auditors and Regulators (i.e. NERC, SERC, and FERC) Effective collaboration, communication, presentation, and relation management skills Leadership of related projects Physical Requirements Must be able to follow established protective measures including wearing required personal protective equipment (PPE). Must possess a valid driver's license and acceptable Motor Vehicle Report. Working Conditions Office environment. Some travel and work outside of normal business hours. While working in certain areas of the plant there is the potential for exposure to hazards typical of an industrial working environment. "Disclaimer - Management may modify this job description at any time and may require the performance of additional duties, or modification of physical requirements, with or without advance notice."
09/25/2026
Full time
Job DescriptionJob Description Position Summary Description The Manager of NERC Compliance oversees a staff of professionals supporting the administrative aspects of Seminole's North American Electric Reliability Corporation (NERC) and Federal Energy Regulatory Commission (FERC) Standards of Conduct compliance programs. This role manages development, implementation, and monitoring efforts toward ensuring compliance of the various operational business areas with all applicable NERC Standards. Collaborates with Seminole leadership, business areas, NERC and regional regulatory agencies on compliance matters. Accountable for spearheading systematic and continuous improvement of the NERC compliance program, its policies, procedures, training materials, and asset lists. Maintains knowledge of current and future regulatory requirements and assesses their impact to the organization. Essential Functions Provides oversight related to compliance with NERC Reliability Standards and FERC Standards of Conduct. Provides oversight during all compliance monitoring functions including on-site audits, spot checks, and self-certifications Collaborates with leadership and business areas to identify and address potential areas of non-compliance and initiate future compliance requirements. Monitors industry best practices and identifies changes in regulatory compliance for cyber and physical security. Provides oversight on compliance assessments, and ensures corrective action is performed to achieve compliance with NERC Reliability Standards. Provides oversight to communication with regional regulatory agencies and internal departments to ensure compliance issues are addressed in a timely manner. Provides oversight of mandatory filings for federal, state, and local regulatory agencies. Represents organization at meetings at the regional and federal level Interprets new and existing NERC regulations in consultation with legal and other subject matter experts to determine applicability. Provides technical leadership in the planning, development, organizational, coordination, implementation, and review of the NERC compliance program. Leads team of personnel in the performance of NERC compliance audits, surveillances, and assessments and is accountable for urgency, accuracy, and overall quality of program. Participates in industry forums and committees to improve overall compliance with NERC and FERC requirements Participates in the NERC Standards Development Process as necessary to ensure Seminole's interests are addressed when existing standards are revised or new standards are proposed. Performs NERC Compliance Program roles if/as designated in Seminole's Standard Ownership Matrix (SOM) including ongoing evidence retention in "audit-ready" form as applicable and directed. You should also be familiar with Seminole's Enterprise Internal Compliance Program (ENT-GCD-RGC-EP-054) to further your understanding of Seminole's compliance program and the context of your duties and responsibilities attendant to your designation in the SOM. Performs other duties as applicable to the position or as assigned. Qualifications and Education Requirements Bachelor's degree in Computer Science, Information Science, Cyber Security, Electrical Engineering, Business Administration, Business Process Management, Auditing, Risk Management. Alternative degrees in combination with specialized experience and/or certifications may be considered. Master's degree or other advance degree preferred. Desire eight (8) years' experience in a combination of the following: NERC Compliance. Information Technology (IT), Cyber Security or comparable experience with emphasis on technical and security domains. Auditing or Risk Management. Electric Utilities experience subject to NERC Standards. Previous supervisory experience preferred Core Competencies: Adaptable, Collaborative, Conscientious, Critical-Thinking, Outcome-Driven and Professional Technical Competencies/Skills: Demonstrated experience: NERC Reliability Standards Program governance, auditing, and risk management Change management, incident reporting and response planning Process lifecycle and improvement plans Enterprise cyber security principles in context of NERC program Transmission, Generation, Distribution, and/or Energy Management Systems Proficiency with Microsoft Office applications Soft Competencies/Skills: Effective verbal/nonverbal, listening and written communications Effective supervision, performance management and talent development Demonstrated: Hands-on design, management, implementation and operationalization of NERC requirements Practical experience of NERC Rules of Procedure and Compliance Monitoring & Enforcement Program Leadership and delivery of high-quality policies and procedures to support effective regulatory compliance Experience of IT/Cyber Security controls (e.g. engineering, architecture, applications, projects) Experience managing departmental budgets, reporting, and management of direct, indirect, and outside resources Effective relationship management with Auditors and Regulators (i.e. NERC, SERC, and FERC) Effective collaboration, communication, presentation, and relation management skills Leadership of related projects Physical Requirements Must be able to follow established protective measures including wearing required personal protective equipment (PPE). Must possess a valid driver's license and acceptable Motor Vehicle Report. Working Conditions Office environment. Some travel and work outside of normal business hours. While working in certain areas of the plant there is the potential for exposure to hazards typical of an industrial working environment. "Disclaimer - Management may modify this job description at any time and may require the performance of additional duties, or modification of physical requirements, with or without advance notice."
Job DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS BA/BS Degree in a Scientific or Engineering discipline 8 + years experience computerized system experience with IT compliance/validation/qualification activities. 8 + years experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 10% travel required. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
09/25/2026
Full time
Job DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS BA/BS Degree in a Scientific or Engineering discipline 8 + years experience computerized system experience with IT compliance/validation/qualification activities. 8 + years experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 10% travel required. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.