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- Kelly Science is seeking a Quality Assurance Manager for a client located near Burlington, MA.
- Oversee and develop CAPA, deviation, risk analysis and change control management.
- Conduct QA in the company's programs, including ensuring Data Integrity in processes, data packages and reports to the Company's external pharma and gene therapy partners.
- Conduct inspections and internal audits in accordance with GCP, GLP and GCLP guidelines to ensure corrective actions are addressed in a timely fashion.
- Scientific or Engineering Degree (BSc, MSc).
- Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy.
- Extensive experience with GCP/GLP compliance required.
- Experience in preparation and participating in inspections by the FDA is and/or other accrediting audits as may be required for GLP or GCP compliant laboratories.
Quality Assurance Manager - Burlington, United States - Kelly Science, Engineering, Technology & Telecom
