Senior Quality Assurance Specialist I *PC 604

Your Role:

This position provides quality assurance oversight for cGMP manufacturing of advanced cell and gene therapy products. Ensures strict compliance with FDA, EMA, ISO and other applicable regulations through real-time shop-floor support, batch record review, and disposition of raw materials and final drug products. This position also supports the implementation of the quality systems in compliance with cGMPs and other company policies.

Essential Duties and Responsibilities:

• Perform review of batch records for intermediate or final product, cell banks including in-process testing, QC release testing data packages, labeling, packaging, and all supporting documentation
• Inspect, review, and disposition raw materials, reagents and components
• Facilitate investigations relating to manufactured products and raw materials
• Provide QA oversight and QA on the floor support during GMP manufacturing operations
• Conduct line clearances, in-process inspections, support final product packaging operations, etc.
• Assist cross-functional teams with the initiation, investigation, and approval of Change Controls, Deviations, and CAPAs, providing critical QA input throughout.
• Create, review and revise standard operating procedures, study protocols, reports, and other GxP documents as needed.
• Coordinate the release of final cell-based therapeutic products for clinical and commercial applications.
• Participate in audit of internal departments, external clients, suppliers, and service providers and completion of audit reports as needed.
• Review and approve validation and qualification packages including installation, operation, and performance qualifications (IQ, OQ, PQ) protocols and reports as necessary.
• Train and provide QA guidance to internal functional groups on Quality Systems.
• Provide environmental monitoring support as needed.
• Participate in internal and client facing meetings as needed.