Specialist I, Product Quality Assurance
Beam Therapeutics
Beam Therapeutics seeks a Specialist II Product Quality Assurance professional to oversee manufacturing and laboratory operations at its Durham, North Carolina facility. The role involves ensuring GMP compliance, batch record review, deviation management, and quality oversight of cell and gene therapy manufacturing across clinical and commercial phases.
Responsibilities
- Provide on-site quality oversight of manufacturing shop floor operations during routine activities
- Review batch records, labels, and QC testing activities for GMP compliance
- Review manufacturing discrepancies, approve CAPAs, and support product disposition
- Approve calibration, maintenance work orders, and asset inductions
- Support equipment commissioning, qualification, validation, and technology transfers
Requirements
- GMP and quality assurance knowledge in manufacturing operations
- Experience with batch record review and regulatory compliance
- Ability to work alternate shifts including first or second shift
- Strong understanding of deviation and CAPA management processes
- Knowledge of quality systems development and procedure authoring
- Familiarity with equipment qualification, validation, and commissioning
Vacancy posted a month ago
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