Quality Assurance Specialist

Job description

Summary The Quality Assurance Specialist ensures cGMP compliance and adherence to SOPs through the review and approval of compliance documentation. Essential Duties and Responsibilities: - Review and approve pre-execution and post-execution batch records to ensure cGMP compliance and adherence to SOPs. - Review and approve components and bulk drug product to ensure proper quality and compliance standards are met. - Review and Approve labels for release to production, ensuring proper quality and compliance standards are met, as required. - Review and approve Analytical Reports/COAs to ensure proper quality and compliance standards are met. - Prepare Annual Product Review (APR) reports in compliance with FDA and EU regulations. - Review and approve Distribution Instructions, Return Instructions and Third-Party Instructions. - Participate/Lead in internal audits and/or supplier audits per schedule and review the results of audits to ensure resolution of any noted deviations. - Assist to write up of audit findings and reports and generation of CAPAs related to audit findings. - Provide timely communication of quality issues to management as needed. - Participate in investigations, devi...