Position Summary
The Senior Quality Assurance Specialist is responsible for the review, approval, and compliance oversight of GMP documentation supporting manufacturing operations and process validation activities. This role partners closely with Manufacturing Sciences & Technology (MS&T) and Manufacturing teams to ensure timely batch record, BOM, and technical document approvals while maintaining compliance with U.S. and EU cGMP regulations.
Key Responsibilities
- Review and approve GMP documentation supporting manufacturing operations, including Master Batch Records, Solution Records, Equipment Preparation Records, Process Assembly Records, Test Sampling Plans, and other manufacturing records as required.
- Collaborate with MS&T and Manufacturing to support BOM review, approval, and release within ASCTrac and SAP systems to ensure production timelines are met.
- Review and approve technical documents associated with process validation and manufacturing operations, including but not limited to:
- Process Characterization
- Process Performance Qualification (PPQ)
- Resin and Membrane Qualifications
- Non-routine Sample Plans
- Provide general QA support to manufacturing operations, including participation in deviation investigations, CAPA development, procedure reviews, and change control assessments, as required.
- Perform compliance review of executed batch records and internal support records to ensure adherence to cGMP and internal quality standards.
- Attend relevant project and operational meetings.
- Support client audits, client meetings, regulatory inspections, and process improvement initiatives as needed.
Qualifications:
- Bachelor’s degree with 10+ years of experience, or Master’s degree with 8+ years of experience, in a QA role within a cGMP-regulated biopharmaceutical (or equivalent) environment.
- Demonstrated experience supporting Manufacturing Process Operations and validation activities in a QA capacity.
- Strong knowledge of U.S. and EU cGMP regulations and guidelines.
- Working knowledge of electronic quality management systems and manufacturing execution systems.
- Working knowledge of electronical management systems
- Familiarity with Operational Excellence principles.
