Full Job Description
Job Summary
The Microbiology Manager/Supervisor oversees microbiology laboratory operations to ensure accurate, timely testing and compliance with regulatory and quality standards. This role leads and mentors laboratory staff, manages resources, and drives continuous improvement in microbiological processes critical to product safety and quality.
Key Responsibilities
Manage day-to-day microbiology laboratory activities, including testing, sample analysis, and reporting.Supervise, train, and mentor microbiology staff to maintain high performance and compliance with procedures.Develop, review, and implement standard operating procedures (SOPs) related to microbiology testing.Ensure compliance with cGMP, FDA, EPA, ISO, and other regulatory requirements.Coordinate and oversee environmental monitoring programs and investigations of microbiological deviations or out-of-specification results.Collaborate with quality assurance, production, and R&D teams to support product release and investigations.Manage laboratory equipment maintenance, calibration, and validation activities.Analyze microbiological data and prepare reports for management and regulatory submissions.Lead continuous improvement initiatives to optimize laboratory workflows and testing efficiency.Maintain strict adherence to health and safety protocols in the laboratory environment.
Required Qualifications
Bachelor's degree in Microbiology, Biology, or related scientific discipline (Master's preferred).Minimum of 5 years' experience in microbiology laboratory testing, with at least 2 years in a supervisory or management role.Strong knowledge of microbiological methods, aseptic techniques, and quality systems.Familiarity with regulatory requirements such as cGMP, FDA, EPA, ISO, and GLP.Excellent leadership, communication, and organizational skills.Proficiency with laboratory information management systems (LIMS) and data analysis software.
Preferred Qualifications
Experience in pharmaceutical, biotechnology, or medical device manufacturing environments.Certifications such as ASCP, CLS, or equivalent microbiology-related credentials.
Certifications
None specifically required, but relevant certifications are a plus.
Education: Bachelors Degree
