- Ensure the quality and integrity of product by testing incoming materials, excipients and final product.
- Perform environmental monitoring of LAL (Limulus Amebocyte Lysate) and Crude Lysate production areas to ensure appropriate conditions are maintained.
- Perform Crude Lysate recovery procedures during the Bleeding Season.
- Attention to detail in all aspects of work is essential.
- Collect samples from production lots to ensure Quality Control testing and Retention storage requirements are met.
- Routinely perform Quality Control release testing of incoming materials and supplies; formulation excipients; final LAL and accessory products.Compliance with Standard Operating Procedures, Specifications and Good Manufacturing Practices must be met.
- Evaluate media via Growth Promotion testing.
- Review of Quality Control data.
- Order and maintain laboratory supplies.
- Develop and review Controlled Documents such as Standard Operating Procedures and Specifications.
- Assist in the execution of protocols.
- Perform testing to support the long-term stability program.
- Perform Internal Audits.
- Interact with customers to support customer audits.
- Perform other related duties as assigned.
Equal Employment Opportunity