The QA Specialist supports review of batch documentation and release of internal and external commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements
Job Summary
The QA Specialist supports review of batch documentation and release of internal and external commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements.
Responsible for certification and/or rejection of incoming material, manufactured material, including intermediates, buffers, virus seed, monobulk and drug product in compliance with applicable licenses and legal requirements.
Ability to answer batch release questions/inquiries, train or coach through progression of experience/knowledge.
Matching Summary
The QA Specialist supports review of batch documentation and release of internal and external commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements.