Title: Quality Batch Review Specialist
Location: Durham, NC
Duration: 12 Months
Job Description:
- The Quality Batch Review Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model.
- The Quality Review Specialist, with guidance from the IPT Quality Release Lead and Quality Review Team, ensures product / process quality, performs activities to ensure that batches are reviewed for any process errors, discrepancies, and documentation errors.
Required Experience and Skills:
- Becomes fully trained in Client Quality SOPs, production SOPs as needed, and SAP functions as required by Quality Specialists.
- Learns cGMPs, the manufacturing process, and Client quality systems.
- Responsible for the review and approval of batches destined for both domestic and international markets
- High school degree is the minimal requirement, but Bachelor’s degree in a scientific discipline is preferred. Technical emphasis in an appropriate Scientific or Engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience.
- A minimum of four years of relevant post-degree work experience in GMP-related field, including Technical, Engineering, Quality or Operations.
- Basic understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
- Basic understanding of the use and maintenance for Microsoft applications (such as MS Excel, MS Outlook, and/or MS Word
- Familiarity with vaccine and/or pharmaceutical processing.
- Familiarity with batch review and batch production systems such as Client-X, MES, etc.
