GMP Operational Quality Sr Specialist

Title: GMP Operational Quality Senior Specialist

Location: Greater Boston Area, MA (Onsite, Sunday–Wednesday, 7:00 AM – 5:30 PM)

Employment Type: Contract (6 months)

Status: Accepting Candidates

About the Role:

Join a QA team in the Cell & Gene Therapy space providing GMP operational support across clinical and commercial manufacturing. This role ensures quality oversight, product disposition, and compliance while supporting cross-functional teams in a high-throughput environment.

Key Responsibilities:

• QA operational support for GMP manufacturing (clinical & commercial drug product)
• Batch record review, batch disposition, and QA data review
• Deviations, investigations, CAPAs, OOS/OOT management
• Quality on the Floor support, walkthroughs, and manufacturing document review
• Support product release, COAs, change controls, and inspection readiness
• Cross-functional collaboration with Manufacturing, QC, Engineering, and Supply Chain
• Participate in process improvements and inspection readiness initiatives
• Provide guidance for product complaints, recalls, and compliance gaps

Qualifications:

• Strong QA Operations background in a GMP environment
• Experience with batch record review, batch disposition, or product release
• Hands-on experience with deviations, investigations, CAPAs, and OOS/OOT
• Exposure to Cell & Gene Therapy or ATMP manufacturing preferred
• Knowledge of GMP, aseptic processing, and CMC regulatory requirements
• Experience with TrackWise, Oracle, or similar QA/ERP systems
• Master’s degree with 2–3 years relevant experience, or Bachelor’s degree with 3–5 years experience
• Comfortable working fully onsite and supporting production floor activities
• Demonstrated success leading cross-functional teams

Compensation (MA Pay Transparency):

• Estimated hourly range: $55–$60/hr (W-2)
• Final rate within this range will be based on skills, experience, and interview results