MENTOR TECHNICAL GROUP CORP

Job Description Job Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. Under general supervision, the Environmental Monitoring and Sampling Coordinator will perform routine procedures and sampling of environmental monitoring, water systems, and gases in support of Manufacturing Operations; plans and prepare the team schedule to achieve a High Performing Team environment; among other tasks. Responsibilities: Under general supervision, this position will perform routine procedures and sampling of environmental monitoring, water systems and gases in support of Manufacturing operations. Complete logs and reports as required. Reviewing shift personnel vs. capacity requirements to run the sampling process as per the scheduled plan. Plans and organizes the area work to achieve a High Performing Team environment. Ensures that work performed by area team members is accurate, timely, efficient and compliant with corporate policies, SOPs, cGMP regulations, and regulatory agencies regulations (FDA, EMEA). Assures a streamlined and continuous process flow of environmental monitoring and sampling area. Perform environmental monitoring routine sample collection, sample receipt, sample incubation, and downstream results analysis, interpretation, and reporting, according to the SOP's. Will also be responsible for documenting and entering data into applicable GMP forms. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, written procedures and logbooks. Ensure timely completion of testing and tasks as assigned (support). Identify opportunities for continuous improvements. Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation of Deviations, CAPAs and Laboratory Investigations, as required by the client sponsor and as indicated in established procedures. Determines team schedule, updates schedule's board, communicates daily schedule performance to team members and communicates the shift production information with other shifts supervisor or manager. Provides input in the creation and revision of SOP's, protocols, and related documents to assure compliance with cGMP's, company policies / procedures and documentation practices. Provides support to the area environmental monitoring and sampling reports. Monitors, evaluates and communicates area performance metrics for processes, cost and quality. Maintains accurate tracking records and provides timely feedback to supervisor regarding status of assigned area/tasks. Provides, in coordination with other departments, the guidance and resources to support validation projects, troubleshooting, lots of production, and process optimization. Ensures the application of cGMP compliance with respect to the Team, shop floor and documentation. Review area documentation to ensure it is complete, accurate, error free, and on time delivery. Follow the Puerto Rico Department of Transportation and Public Works (DTOP) regulations and safety standards. Trains the Team on any necessary compliance and quality requirements related with the area or the business. Demonstrated ability to deliver results in a real time environment Attention and dedication to quality. Demonstrated ability to deliver results in a real-time environment Be a team player Ability to work shift hours supporting 24/7 operations Qualifications Requirements/Knowledge/Education/Skills: Bachelor's degree or associate degree & 4 years of directly related experience A minimum of two (2) years in laboratory experience, preferably in the Manufacturing /Pharmaceutical Industry is required. Valid PR Driver's license issued by the Puerto Rico Department of Transportation and Public Works (DTOP) with a clean motor vehicle record (MVR) with no serious infractions in the past 5 years. Experience working in a cleanroom environment. Is highly preferred. Previous experience leading teams, projects or initiatives and/or demonstrated a high level of leadership skills is highly preferred. Strong knowledge and understanding of GMP, regulatory requirements, written procedures, methods and safety guidelines. Knowledge and experience in sampling processes for utilities and viable / non-viable environmental monitoring. Excellent leadership characteristics, accountability and commitment. Good communications, planning, problem solving and interpersonal skills Self-starter and able to make decisions of simple situations at work. Full knowledge of cGMP and EHS practices. Ability to read and comprehend detailed technical information/ directions. Computer Software Skills in Microsoft Office Suite (Word, Excel, Power Point), SAP/ERP, eBR, LIMS, and Trackwise among others.Microsoft office (Word, Excel, Outlook) in a beginner to intermediate level. Ability to work in a team environment, to collaborate and coordinate with internal and external staff at all levels, and to prioritize multiple responsibilities, tasks and projects simultaneously. Good communication skills and presentation skills, (both written and verbal). Organization skills and talent to perform assignments with a high degree of attention to detail. Work in a team environment with the flexibility to work shifts as scheduled (weekends, holidays as required) Intermediate math skills with an ability to calculate with percentages and decimals are required. The ability to understand and interpret both written and oral communication in English is a plus. The COVID-19 vaccine is / may be a condition of employment. Physical Requirements and Working Environment: While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. Work in areas that may have strong magnets. May work in areas with exposure to utility areas (vapor, gasses, high temperature, among others). Must have the ability to work assigned shifts (Day, Night, Weekends, and/or holidays). Require working in and around laboratories and controlled, enclosed, restricted areas, including clean rooms. No make-up, nail polish, and/or jewelry may be worn in the GMP process areas. Ability to fully gowned including head covering, facemask, gloves, plant shoes, safety glasses/goggles, and/or face shield. Ability to wear PPE face covers for pandemics compliance when required. Ability to wear PPE and follow indications for the management of hot water samples. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.