What are the responsibilities and job description for the QC Microbiologist II position at Aveva Drug Delivery Systems?
Description
Job Summary:
The QC Microbiologist II performs microbiological testing of raw materials, intermediate/finished products, and environmental bio-burden. He/She maintains a functional and current GMP compliant microbiology laboratory.
Job Responsibilities
Job Requirements
Job Summary:
The QC Microbiologist II performs microbiological testing of raw materials, intermediate/finished products, and environmental bio-burden. He/She maintains a functional and current GMP compliant microbiology laboratory.
Job Responsibilities
- Perform Microbial Limits and Microbial Limits Validation assay of finished products, raw materials, and components 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.
- 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, bio-burden and author reports.
- Perform IQ/OQ/PQ on instruments and author the protocols/reports.
- 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.
- 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
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 2-4 years laboratory experience.
- Master's degree (M.S) in microbiology and a minimum of 1-2 years laboratory experience.