Primary role: Quality Assurance (QA) for current Good Manufacturing Practice (cGMP)-compliant programs is responsible for ensuring that components, intermediates, drug substance, and drug product are of the quality required for their intended use and that quality systems are maintained. With assistance and oversight, the QA Associate I will perform a variety of duties associated with the Office of Regulatory Affairs and Quality in support of the cGMP programs at Duke University, including critical review of deviations and investigations, review/revision of SOPs, inspection/release of materials, qualification of critical suppliers, review of batch records for product release, audit of programs under ORAQ’s purview, and quality training. This positi
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