- Review and providing feedback on GMP documentation including equipment qualifications, analytical method qualifications, stability protocols, product monographs, and SOPs.
- Review and release raw materials and components to be used in the manufacture of clinical and/or commercial products.
- Provide QA support and oversight during the production and testing of drug product.
- Review executed batch records, analytical test results and raw data as part of product release. As required, work to resolve identified issues to support timely release of product that conforms to specifications.
- Support and review investigations related to deviations or out-of-specifications and the implementation of corrective and preventive actions that mitigate potential for reoccurrence.
- Communicate quality-related input to project teams while participating in project or client meetings.
- Provide new employee orientation and curricula issuance in coordination with department heads. Ensure ongoing employee compliance with training procedures.
- Participate in the planning and execution of customer audits. As required, support the drafting of responses to client audit findings to assure they meet the client's expectations.
- Participate in regulatory inspections to ensure successful results.
- Participate in supplier quality assessments to ensure suppliers and subcontractors to be used are properly qualified in accordance with the supplier management program.
- Minimum of a Bachelor's degree in a scientific field
- Minimum three (3) years related experience in QA or five (5) years in QC
- Strong analytical skills and attention to details required