Job DetailsJob Location: Tamarac, FL 33321Job 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.
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