Microbiology Supervisor

Job Description

The Microbiology Supervisor is responsible for conducting USP microbiological quality control testing on various products, including FDA-regulated over-the-counter (OTC) drugs, cosmetics, EPA-registered disinfectants, and unregulated formulations. This role involves establishing action and alert limits for microbial monitoring according to FDA guidance and industry standards. The supervisor oversees the collection, testing, and documentation of environmental monitoring samples to ensure facility cleanliness and compliance. Additional responsibilities include the preparation and maintenance of laboratory materials and equipment.

Responsibilities

• Ensure compliance with cGMP, GLP, and applicable standards.
• Adhere to all microbiology-related Standard Operating Procedures (SOPs) and maintain accurate, detailed records of all testing activities.
• Develop and implement method validation and verification studies as required.
• Investigate and document Out-of-Specification (OOS) results and deviations, including root cause analysis and corrective actions.
• Support internal and external audits related to microbiology.
• Conduct microbiological testing on raw materials, in-process samples, and finished products.
• Perform environmental monitoring of manufacturing areas, cleanrooms, and utilities.
• Recommend and implement improvements to manufacturing practices to enhance microbial hygiene.
• Execute microbial identification using various validated methods and technologies.
• Conduct preservative efficacy testing and antimicrobial effectiveness testing per USP standards.
• Maintain a clean, organized, and safe laboratory environment.
• Ensure laboratory notebooks and electronic records comply with regulatory requirements.
• Participate in and support process improvement initiatives within the microbiology lab.
• Stay informed on industry trends, regulatory changes, and advancements in microbiological testing.
• Implement new methods and technologies to remain compliant with FDA standards.
• Perform daily procedures to ensure the laboratory is fully functional, including sanitization, equipment preparation, and material receipt.
• Ensure laboratories are consistently clean and presentable for visitors and auditors.
• Ensure timely processing of all microbiological samples.
• Operate, maintain, and troubleshoot laboratory equipment as needed.
• Manage inventory of laboratory supplies, reagents, and culture collections.
• Apply aseptic techniques to ensure sterility during testing and monitor for potential contamination sources related to personnel or equipment.
• Conduct testing and documentation in alignment with applicable USP methods and procedures.
• Prepare culture media, reagents, and materials required for microbial testing.
• Perform microbial techniques including dilutions, culture propagation, isolation/purity plating, colony enumeration, Gram staining, and microbial screening.
• Maintain cryopreserved cultures for laboratory testing purposes.
• Write, review, and revise SOPs as required.
• Conduct weekly data reviews to ensure compliance with regulatory standards and internal quality expectations.

Essential Skills

• Bachelor’s degree in Microbiology, Biology, or a related scientific field; advanced degree preferred.
• 5–10 years of experience in Quality Control Microbiology, preferably within the pharmaceutical, cosmetic, or related regulated industries.
• 3–5 years of hands-on microbiology experience in a manufacturing environment.
• Strong proficiency in core microbiological techniques, including aseptic technique, microbial enumeration, and microbial identification methods.
• In-depth understanding of regulatory requirements and guidelines issued by the FDA, EPA, and other relevant agencies.
• Experience with hygienic manufacturing practices, including root cause analysis of microbial contamination and design of effective preservation systems.
• Demonstrated ability to write and execute validations for microbiological test methods.
• Ability to collect microbiological samples from manufacturing equipment, raw material containers, and bulk storage tanks.
• Exceptional attention to detail with strong analytical and problem-solving skills.
• Effective written and verbal communication skills.
• Proven ability to work both independently and collaboratively in a fast-paced, team-oriented environment.

Additional Skills & Qualifications

• The ideal candidate will combine technical expertise in microbiology with a commitment to quality and regulatory compliance, supporting the team in maintaining the highest standards of product safety and efficacy.

Work Environment

The role involves working in a laboratory environment, requiring the ability to stand for long periods and lift at least 50 pounds