- Wilson, North Carolina, United States
- On-site
- Full-time · Senior
- 6+ years
Seeking a highly qualified Senior QA Specialist to join a new Biotherapeutics Manufacturing facility in Wilson, NC, ensuring compliance with regulatory requirements and GMP policies throughout the C&Q validation lifecycle.
Responsibilities
- Represents Quality Assurance on qualification teams and provides QA oversight of C&Q and validation execution across the capital project lifecycle—user requirements, design review, construction, FAT/SAT, commissioning, qualification and handover.
- Supports development and maintenance of site validation program, Validation Master Plan, and project C&Q and validation plans.
- Participates in risk assessments (FMEA, HACCP, HAZOP, ICH Q9(R1), CARA) for equipment, utilities and systems.
- Reviews and approves commissioning and qualification documentation, including URS, FAT/SAT, IQ/OQ/PQ protocols, and reports.
- Ensures Good Documentation Practice and data integrity of vendor, EPCM and CQV contractor documentation.
Requirements
- Bachelor's degree in a scientific or engineering discipline
- Master's degree in a scientific or engineering discipline
- Nice to have: greenfield or start-up facility experience
- Nice to have: ASQ certification (CQA, CQE)
- Nice to have: Kneat