Summary from listing
The Quality Assurance Release Specialist reviews and approves batch records, certificates of analysis and conformance, USDA and international release documentation, change controls, deviations, CAPAs, and SAP batch-release transactions. The role supports compliance with USDA, FDA, EU, and cGMP requirements across BIAH manufacturing and third-party contract manufacturing, and may lead assigned projects. A relevant BS degree plus two years of experience or an MS degree in a relevant scientific discipline is required, along with knowledge of regulated biological processes, SAP, and strong analytical and communication skills.
