Principal QA Specialist

We are seeking a Principal Quality Assurance Specialist to provide QA support to manufacturing process operations within a cGMP biopharmaceutical environment. This role partners closely with Manufacturing and MS&T to ensure compliant batch execution, documentation, and validation activities.

Key Responsibilities

• Review and approve Master Batch Records, solution, equipment prep, process assembly, and test sampling plans
• Support BOM review, approval, and release in ASCTrac/SAP to meet production timelines
• Review and approve validation and technical documents (Process Characterization, PPQ, resin/membrane qualifications, non‑routine sampling plans)
• Provide QA floor support including deviations, CAPAs, change controls, and procedures
• Perform compliance review of executed batch records
• Support audits, regulatory inspections, and continuous improvement initiatives
• Mentor and support training of QA staff

Qualifications

• BS + 10+ years or MS + 8+ years in QA within a cGMP biopharmaceutical environment
• Direct experience supporting manufacturing operations and process validation
• Strong knowledge of US/EU cGMP regulations
• Experience with electronic document systems and ERP tools (SAP preferred)
• Excellent written and verbal communication skills