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cGMP Quality Assurance Specialist
USCâs Keck School of Medicine, Department of Medicine is seeking a dynamic individual to establish and manage Quality Assurance system for manufacturing cell and gene therapies and other biological products for internal/external users in the universityâs current Good Manufacturing Practices (cGMP) facility. Â The Quality Assurance Specialist is responsible for ensuring operations quality and compliance with current Good Manufacturing Practice (cGMP) regulations. Establishes, controls, monitors and records all activities, which directly/indirectly impact aspects of cell therapy product quality. Establishes a Corrective and Preventative Actions (CAPA) system that manages the response to errors, accidents, complaints and clinical trial-related adverse events. Ensures that cell the
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