Lead QC analysts in analytical testing of in-process and final cell therapy products.
Ensure GxP and safety standards are met in the QC lab with regulatory compliance.
Create/Review/Approve COA, test methods, and method validation documents.
Investigate OOS results and manage deviations related to analytical procedures.
Manage QC equipment validation, calibration, maintenance, and troubleshooting.
Train analysts, support internal assessments/audits, and serve as QM liaison across functions.

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