QC Microbiologist II

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
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.