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The Quality Control Analyst I is responsible for performing laboratory activities supporting GMP testing. Duties include endotoxin testing, gram staining, bioburden testing, and maintaining compliance with documentation practices. The analyst communicates lab issues, participates in investigations, and contributes to improving QC procedures and systems within a GMP environment.

The Manager of Quality Assurance oversees activities related to the manufacturing of cell and gene therapy products, ensuring compliance with quality systems, cGMP guidelines, and regulatory requirements. Responsibilities include batch record review, employee training, maintaining document control, and participating in inspections and continuous improvement activities.

The Specialist I in Quality Assurance will handle routine activities in manufacturing, focusing on the creation and review of GxP controlled documents, managing the document lifecycle, and ensuring compliance with quality standards. This includes editing, formatting, and archiving documents and supporting inspections as needed.