POSITION OBJECTIVE: Responsible for validation, performance, and review of all aspects of analytical testing and environmental monitoring that takes place in the Microbiology department. Will also provide direct support to Microbiology Supervision in all relevant types of investigations and personnel planning.  

Essential Job Functions/Responsibilities

• Design, perform, review, and approve microbiology testing product validations (sterility, endotoxin, Microbial Enumeration) and clean room qualifications.
• Scheduling/assistance in scheduling of department Analysts and Technicians.
• Improve process and sample flows in the laboratory for more efficient material and personnel movements.
• Perform, review, approve (and provide results or extension by due dates) for laboratory investigations (LIR), issue reviews (ISSUE), discrepancy investigations (DIR), environmental excursions (EE), out of specification reports (OOS), and corrective action-preventative action reports (CAPA) in a timely manner.
• Provides oversight for Microbiology department functions included but not limited to: Media Fill program, Environmental Surveillance Team, ID/Trending Program, Excursion Investigations, providing audit response information, Lab supply system, and Gowning Program.
• Performance (if needed), review, approval of Sterility
• Performance (if needed), review, approval of environmental monitoring of ISO5/ISO7/ISO8 manufacturing areas (viable air, viable surface, and non-viable particulate) as well as inspection for compliance.
• Support Media Fill Validations, Engineering Validations and Cleaning Validations.
• Perform (if needed), review, and approve of testing (Bioburden/TOC/Conductivity) of water samples from throughout the facility.
• Perform (if needed), review, and approve of raw Material/Prefiltration Bioburden sample testing.
• Perform (if needed), review, and approve media check in, growth promotion, equipment preparation, autoclaving, preparation of microbial ID samples and off testing of incubated microbial media and plates.
• Oversight of stocking/ordering lab supplies.
• Revision of microbiology/laboratory procedures.
• Responsible for promoting and maintaining safe and healthy working conditions in his/her assigned work area; instructs and enforces compliance with established safe work practices and procedures; ensures assigned trainees receive appropriate training and information necessary to conduct their activities in a safe and healthy manner.
• May perform other duties as assigned.