Job Summary:

The QC Microbiologist | performs microbiological testing of raw materials, intermediate/finished products, and environmental monitoring. He/She maintains a functional and current GMP compliant microbiology laboratory.

Job Responsibilities

• Perform microbial testing of finished products, raw materials, and components in a timely manner.
• Perform environmental monitoring of the manufacturing facility.
• Review current USP and the regulatory guidance to ensure compliance with current microbiological methods and practices.
• Responsible for daily monitoring and testing of the Purified Water System, and WFI System.
• Author, and review of microbiology protocols, reports, STP's and SOP's.
• Responsible for microbiology testing for weekend and holiday schedules, as needed.
• Performs trend analysis of microbiology test results from products, water system, environmental monitoring, and author reports.
• Required to participate in audits and/or consultations with other departments, as required.
• General procurement assignments and responsibilities for the microbiology laboratory: monitor housekeeping, biohazard waste disposal, sample discard, discard of expired media and reagents, instrument calibration/maintenance/daily monitoring, and inventory/ordering.
• Works as a member of a team to achieve all outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
• All other relevant duties as assigned.