Quality Assurance Specialist III

Job description

About this opportunity: The position is responsible for documenting and auditing cGMP practices for the site. The position develops and revises QA procedures to strengthen cGMP compliance. Key Responsibilities: - Responsible for reviewing quality records/batch records - Co-host during vendor/internal quality audits to ensure that cGMP compliance is at the required standard for API manufacture, in accordance with ICH Q7 Guidance and FDA 21 CFR requirements. - Provide cGMP training to site staff as needed and assure that there is full understanding of the Cincinnati site Quality procedures. - Responsible for writing/revising Quality Assurance procedures to strengthen compliance with cGMPs. - Review and approve deviations, OOT and OOS. - Provide strong link/communication between the QA function/activities with all other departments at the Cincinnati site. - Act as QA representative on project teams. Reviewer of project documents (BRs, Technical Reports, Validation documents) - Review Certificates of Analysis (COA) and Certificates of Conformance (CoC) for accuracy and release product. - Provide assistance during cGMP compliance inspections of the Cincinnati facility. This includes the...