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 quality systems in compliance with cGMPs and other company policies.

Essential Duties and Responsibilities
Perform review of batch records for intermediate or final products, 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, and support final product packaging operations.
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 audits of internal departments, external clients, suppliers, and service providers, and complete audit reports as needed.
Review and approve validation and qualification packages, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (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.

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