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The Microbiology Supervisor is responsible for overseeing the operations of the microbiology laboratory. Duties include managing direct reports, acting as Subject Matter Expert (SME) and contributing to audit-readiness. Perform routine testing and per review as needed.
Job Responsibility:
Management of lab staff direct reports including completion of performance feedback, reviews, disciplinary action and timecard administration
Ensure testing is initiated and performed in a timely manner and adhering to quality standards
Act as laboratory SME
Draft protocols and coordinate with laboratory manager to conduct investigations and special studies as needed
Draft and edit SOPs as needed
Approve CoAs as needed
Conduct and/or approve method suitability as needed
Adhere to SOPs and regulatory requirements such as GMPs, GDPs, GLPs and OSHA regulations
Perform microbiological testing and method validation related for the following microbiological test methods: Sterility Testing per USP <71>
Endotoxin per USP <85>
Particulate Matter per USP <788>, <789>, <787>
Water for Pharmaceutical Purpose <1231>
Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests <61>
Other tests as needed
Microbiological growth promotion
Adhere to controlled substance requirements
Receive, and release media, buffers, and microorganism cultures
Update and review microbiological trending
Compose, update, and review procedures and training materials
Sanitize the laboratory incubators and refrigerators
Maintain and coordinate equipment / instrumentation maintenance, calibration, and repair work
Clean and sanitize the microbiology laboratory rooms surfaces and equipment
Manage personal time off by requesting the time off in company time keeping system for either PTO or VPTO according to company policy for salary employees as well as approving requests for direct reports
Other duties as assigned
Requirements:
Bachelor's degree in microbiology, biology, or related scientific field or equivalent experience, graduate degree is a plus
Prior management experience preferred
Six (6)+ years of experience in a pharmaceutical microbiology laboratory, combined laboratory and pharmaceutical quality experience will be considered (graduate degree may be considered as contribution to experience)
Knowledge of cGMP/GLP/GDP, USP, FDA regulatory requirements
Experience performing microbiological testing / environmental monitoring using aseptic techniques
Excellent interpersonal communication and organizational skills
Demonstrated leadership skills
Qualified to work with controlled substances
Experience Handling Biohazardous materials
Ability to interpret technical documents
Proficiency in technical writing with an emphasis of deviations, CAPAs, etc.
Project Management experience a plus
Must be comfortable interacting within multiple areas of an organization and be able to communicate technical content in a concise and clear manner