Description
Summary
The Microbiologist plays a crucial role in ensuring the safety and quality of nutraceutical products. This role is integral to maintaining the microbiological integrity of raw materials, finished products, packaging components, production environments, and processes. The ideal candidate brings strong technical expertise, a deep understanding of regulatory requirements governing the dietary supplement industry, and leadership capabilities within a GMP-compliant lab setting. Compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), ISO/IEC 17025, laboratory safety, and applicable regulatory requirements is essential.
This role ensures product safety and quality by developing and executing validated microbiological methods, maintaining accurate documentation, and supporting regulatory and client audits.
Responsibilities
Perform and oversee microbiological testing of raw materials, in-process materials, finished products, and packaging components per FDA, USP, and internal specifications.
Author, review, and revise Standard Operating Procedures (SOPs), validation protocols, test methods, and other controlled documents.
Act as the microbiology subject matter expert (SME) during internal and external audits and inspections, including FDA and third-party audits.
Oversee environmental monitoring programs and ensure compliance with hygiene standards, including air, surface, water, and personnel monitoring; trend and report results.
Support cross-functional teams on contamination control strategies and microbiological risk assessments.
Train and mentor junior microbiologists and lab technicians on aseptic techniques, compliance, and best practices.
Maintain, calibrate, and troubleshoot microbiology laboratory equipment; ensure audit readiness.
Stay current on industry trends, emerging pathogens, and regulatory changes impacting microbiological testing.
Monitor and review outsourced microbiological test results; investigate discrepancies.
Provide guidance on laboratory safety practices, including response to accidents and pathogen exposure.
Conduct and document cleaning and sanitization verification, including ATP and microbiological swabbing.
Develop, validate, and implement microbiological methods and techniques, including rapid methods where applicable.
Evaluate and interpret complex data; identify trends and prepare reports for management.
Lead and document investigations into out-of-specification (OOS) or atypical results, including root cause analysis and CAPA.
Support customer complaint investigations related to microbiological quality.
Provide expertise to support specification setting, client discussions, and regulatory compliance.
Deliver microbiology, sanitation, and GMP training to lab and production personnel.
Ensure data integrity, GDP compliance, and traceability in all records and reports.
Contribute to facility cleaning and sanitization master plans.
Participate in internal audits, supplier audits, and regulatory/client inspections.
Provide regular updates to QC leadership and escalate issues as needed.
Perform additional duties as assigned.
Requirements
Minimum Qualifications
Education/Knowledge
Bachelor of Science or Master’s degree in Microbiology or a related scientific field.
Experience
Minimum 3 years of experience in a GMP-regulated microbiology laboratory, preferably within dietary supplements, pharmaceuticals, or food manufacturing.
Strong knowledge of microbiological methods (USP <61>, <62>, <2021>, <2022>, etc.) and regulatory guidelines (21 CFR Part 111, 21 CFR Part 117).
Demonstrated ability in method validation, investigations, and technical reporting.
Proficient in laboratory documentation, data integrity, and LIMS or digital systems.
Hands-on experience with core microbiological testing (APC, yeast & mold, coliforms, E. coli, S. aureus, Salmonella, etc.).
Experience supporting regulatory inspections (FDA, NSF, UL, or equivalent).
Strong problem-solving and decision-making skills.
Effective communication and presentation skills for cross-functional teams.
Strong organizational skills with the ability to manage multiple priorities.
Self-starter with a collaborative mindset, committed to safety, compliance, and continuous improvement.
