Our client, a global biopharmaceutical company that finds and delivers novel treatments for patients with a significant unmet need, has an immediate opening for a Sr. Specialist, QA.
- Oversee operations and external quality control laboratories
- Review and approve GMP documents that support qualification of test methods and reference standards, including protocols, data, and reports
- Review and approve laboratory data related to release and stability of GMP materials
- Review electronic records including audit trails
- Collaborate with Quality Control and Analytical Development to support the timely review of documents
- Oversee integrity of data and results generated and external laboratories
- Bachelor’s degree in a scientific discipline with 4+ years of experience in the pharmaceutical/biotech industry in combination with analytical development and quality. Biologics experience is preferred.
- Hands on experience with laboratory testing and method validation
- Familiarity with a wide range of test methods needed for evaluation of diverse samples, such as cell banks, drug substance, drug product, and combination products is a plus
- Excellent verbal and written communication skills
- Strong team player that has a customer service approach and is solution oriented
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors