Job Summary:
The QC Microbiologist I performs microbiological testing of DI water, intermediate/finished products, and environmental bio-burden. He/She maintains a functional and current GMP compliant microbiology laboratory.
Job Responsibilities
• Perform Microbial Limits Testing on finished products, and raw materials in a timely manner.
• Perform bio-burden monitoring of the manufacturing facility and the microbiology laboratory.
• Review current USP and the regulatory guidance to ensure compliance with current microbiological methods and practices.
• Responsible for daily monitoring and testing of the USP Purified Water System.
• Support microbiology testing for weekend and holiday schedules, as needed.
• Attend seminars on special topics to continually evaluate improvements to the microbiology laboratory, testing, and policy.
• Required to participate in audits and/or consultations with other departments, as required.
• General procurement assignments and responsibilities for the microbiology laboratory: monitor housekeeping, bio hazard waste disposal, sample discard, discard of expired reagents, media preparation, sterilization of waste and glassware, instrument calibration/maintenance/daily monitoring, quarterly expenses report, and inventory/ordering.
• 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
