About The Role

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