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Quality Assurance Specialist

Posted 4 days ago

tekprosolPrinceton (NJ)

SENIORITY

Lead

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About the role

Provide Quality Assurance and regulatorysupport across Pharmaceutical, Biotech and CRO industries, Ensure compliancewith GxP (GMP, GLP, GCP, GDP) regulations, Internal Audit management, CAPAoversight, and eTMF audit responses. Support GMP biologics manufacturing withexposure to viral vector processes, aseptic operations and complex cell-basedsystems. Develop and support audit programs, monitor compliance metrics andimplement data-driven process improvements in alignment with FDA, EMA, ISO andICH standards, Cross-functional collaboration. Master'sdegree in Science, Technology, Business Administration, or Engineering (Any) isrequired.
Work location: Princeton, NJ and various unanticipated locationsthroughout the U.S. Skills & Keywords Quality Assurance Specialist

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