The Quality Assurance Specialist III is responsible for documenting, auditing, and ensuring cGMP compliance at the site.
Key duties include reviewing quality and batch records, co-hosting vendor/internal audits, providing cGMP training, and revising QA procedures to enhance compliance.
The role involves reviewing deviations, OOT/OOS, project documents, COAs, and CoCs, and supporting cGMP inspections by retrieving relevant records.
The ideal candidate has a BS/BA in science or equivalent, with 3-5 years of experience in Production or QA, and expert knowledge of cGMP regulations.
Strong attention to detail, decision-making skills, and current knowledge of evolving regulatory requirements are essential.
This position acts as a liaison across departments and participates in project teams to maintain quality standards.