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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- 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.
- Education: Bachelors degree (BA/BS) in a scientific discipline or related field
- Experience: One to two years experience with GMP products preferred. Prior experience with laboratory operations and auditing preferred.
- Certification/Licensure: None
- Other: Computer literacy must include word processing, spreadsheet and advanced math skills.
Equal Employment Opportunity
Our company is an Equal Opportunity Employer M/F/Disabled/Vet