The Quality Assurance Specialist role supports the introduction and execution of new products, materials, and drug substances into the Carlow facility. The QA Specialist (NPI / DS / Materials) will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product development and manufacture, along with day-to-day QA activities, including:
1.Ensuring that the process for the introduction of biologics/vaccines is in compliance with cGMP and the associated regulatory requirements.
2.Reviewing and approving documentation to support corporate compliance/regulatory expectations for manufacturing.
3.QA oversight on the receipt and release of Drug Substance to site.
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