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Sr. QA Specialist
|Job State:||US - Pennsylvania|
|Client Project Number:||9282|
The Senior QA Specialist will ensure that all QA regulatory requirements are met for the transfer of products, per regulations and the clients' policies and SOPs. This person will also be a member of the core Technical Transfer Team, overseeing and managing a portfolio of worldwide tech transfers. In that capacity, the incumbent will interact closely with the sending & receiving sites and corporate functions of the client organization.
Strong knowledge of Quality Assurance for commercial manufacturing(U.S. and EU regulations), validation and a strong knowledge of a sterile filing operation. Knowledge of vaccine is preferred and a solid understanding of technical transfers from a QA perspective is required. Experience interacting with CMOs is strongly preferred.
10 years in a QA role in commercial manufacturing
Scientific or Engineering degree ( i.e.Bio-Chemical Engineering, Microbiology or Molecular Biology )
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