Quality Assurance Manager

3 weeks ago


Burlington, Vermont, United States Kelly Science, Engineering, Technology & Telecom Full time

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.



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