Job Description
Function: Quality Systems / Continuous Improvement
Focus: Formulation & Filling
Manager Notes:
- Must Have: Bachelor's degree and 3-5 years of relevant experience
- Strong experience with deviations, Quality Systems, continuous improvement, and regulated GMP pharmaceutical or biotech manufacturing environments.
- Experience with eBR, Opstrakker, MES, or similar digital manufacturing systems.
- Experience with comparable Quality systems such as Qualipso/Veeva is acceptable.
- Nice to Have Experience/ Skills: Previous biotech and/or pharmaceutical manufacturing experience strongly preferred.
- Familiarity with OEE (Overall Equipment Effectiveness) and using performance metrics to identify equipment/process improvement opportunities.
- Background in formulation, filling, lyophilization (freeze-drying), and/or inspection is a plus.
Position Summary
- The Quality Systems / Continuous Improvement Contractor will provide dedicated support to pharmaceutical manufacturing operations, with a primary focus on Formulation and Filling.
- This position will partner with Quality, Operations, Engineering, MSAT, Sterility Assurance, and other cross-functional teams to drive CAPA, Change Control, quality investigations, root cause analysis, and continuous improvement initiatives while maintaining compliance with cGMP and regulatory requirements.
Key Responsibilities
- Serve as the CAPA and Change Control point of contact supporting Formulation and Filling improvement initiatives.
- Independently manage CAPA and Change Control actions, ensuring accurate documentation and timely closure.
- Lead quality investigations, troubleshooting, root cause analysis, product impact assessments, and corrective/preventive actions.
- Partner with SMEs and cross-functional stakeholders to resolve manufacturing and quality issues.
- Provide technical support for component qualification, Overall Equipment Effectiveness (OEE), electronic Batch Records (eBR), Opstrakker, and factory improvement initiatives.
- Support continuous improvement efforts utilizing Lean Manufacturing, Six Sigma, and +QDCI Visual Management principles.
- Monitor and communicate key performance metrics and identify opportunities for process improvement.
- Author and maintain high-quality protocols, technical reports, investigations, CAPAs, and Change Controls.
- Ensure compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulatory requirements.
- Support regulatory inspections and audits as required.
Required Qualifications
- Minimum Education: Bachelor's degree.
- Experience: Minimum 3-5 years of relevant experience in pharmaceutical manufacturing, Quality Systems, Continuous Improvement, or a related regulated environment.
- Strong knowledge of cGMP requirements and pharmaceutical manufacturing operations.
- Experience with formulation, filling, lyophilization, and/or inspection processes.
- Experience managing CAPAs, Change Controls, quality investigations, and root cause analysis.
- Knowledge of Lean Manufacturing and Six Sigma methodologies.
- Strong technical writing, project management, problem-solving, and cross-functional communication skills.
- Proficiency in Microsoft Excel, Word, and PowerPoint.
- Experience with iShift, Qualipso, eBR, and Opstrakker preferred.