About this role
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.
Qualifications
Job Requirements
- Education
- Bachelor's degree (B.S.) in microbiology or equivalent.
- Knowledge, Skills and Abilities
- FDA, cGMPs, and SOPs related to job requirements.
- Experience
- Minimum of 0-2 years of laboratory experience.