QC Microbiologist II

Microbiologist IIJob 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

QualificationsJob Requirements

• Education

o Bachelor's degree (B. S.) in microbiology or equivalent

• Knowledge, Skills and Abilities

o FDA, cGMPs, and SOPs related to job requirements.

• Experience

o Minimum of 2-4 years laboratory experience.
o Master's degree (M.S) in microbiology and a minimum of 1-2 years laboratory experience.