Microbiologist

Summary

The Microbiologist is responsible for supporting the microbiological control program and ensuring the safety, quality, identity, purity, and regulatory compliance of dietary supplement ingredients, in-process materials, finished products, water systems, and the manufacturing environment. This position performs microbiological testing and monitoring activities in accordance with 21 CFR Part 111, applicable USP compendial methods, approved specifications, Standard Operating Procedures (SOPs), and Good Documentation Practices (GDP).

Key Responsibilities

• Microbiological Testing: Perform routine and non-routine microbiological testing of raw materials, in-process materials, finished dietary supplements, water, and other applicable samples according to approved specifications and established laboratory procedures. 
• Compendial Testing: Perform microbiological testing using applicable compendial methodologies, including USP <61> Microbial Enumeration Tests, USP <62> Tests for Specified Microorganisms, and other applicable USP chapters or validated methods. 
• Environmental Monitoring: Execute and document the facility's Environmental Monitoring Program, including surface swabbing, air monitoring, water/utility sampling, and other microbiological monitoring activities designed to identify and control potential sources of contamination. 
• Cleaning & Sanitation Verification: Support verification of cleaning and sanitation effectiveness through microbiological surface sampling, ATP monitoring where applicable, trending, and evaluation of results. Assist with investigations when established alert or action limits are exceeded. 
• Laboratory Practices & Aseptic Technique: Maintain appropriate microbiological and aseptic techniques to prevent cross-contamination and ensure the integrity of samples, cultures, media, and test results. 
•  Laboratory Investigations / OOS: Initiate, conduct, and support investigations of Out-of-Specification (OOS), Out-of-Trend (OOT), atypical, or questionable microbiological results. Participate in root-cause analysis and development of scientifically justified corrective and preventive actions (CAPA). 
• Data Review & Trending: Review and analyze microbiological results for trends, recurring contamination, adverse conditions, or other potential quality concerns. Promptly communicate significant findings to Quality management. 
• Method Qualification & Validation: Support the development, verification, validation, transfer, and implementation of microbiological test methods. Ensure methods are scientifically appropriate for their intended use and consistent with applicable regulatory and compendial requirements. 
• Growth Promotion & Media Controls: Perform or oversee appropriate media preparation, growth-promotion testing, sterility checks, positive/negative controls, and other laboratory controls necessary to demonstrate the suitability of microbiological testing. 
• Laboratory Documentation: Maintain complete, accurate, contemporaneous, attributable, and traceable laboratory records, worksheets, logbooks, electronic records, and supporting documentation in accordance with cGMP, GDP, and established SOPs. 
•  Specifications & Quality Control: Support establishment and maintenance of appropriate microbiological specifications and acceptance criteria for components, in-process materials, finished products, water, and environmental monitoring programs. 
• Equipment Management: Operate and maintain microbiology laboratory equipment, including incubators, autoclaves, colony counters, balances, pipettes, air samplers, and other applicable instruments. Ensure equipment is appropriately calibrated, qualified, maintained, and documented before use. 
• Culture & Reference Standard Control: Maintain appropriate control, handling, storage, traceability, and documentation of microbial cultures, reference organisms, reagents, and laboratory materials. 
• Sample Management: Ensure microbiological samples are properly collected, identified, handled, stored, tested, and documented to maintain sample integrity and traceability. 
• SOP & Controlled Document Management: Draft, review, revise, and maintain SOPs, test methods, protocols, specifications, forms, technical reports, and other controlled documents related to microbiological laboratory activities. 
• Product & Material Disposition Support: Provide microbiological test results and technical assessments to Quality Assurance/Quality Control to support the disposition of components, materials, and finished products. Final approval or rejection remains with the designated Quality Control personnel in accordance with 21 CFR Part 111. 
• Audit & Inspection Support: Participate in internal audits, third-party certification audits, customer audits, and regulatory inspections. Provide laboratory records and technical explanations and assist with responses and corrective actions related to microbiological observations. 
• Training: Provide microbiology, contamination-control, sampling, laboratory practices, and applicable cGMP training to laboratory, Quality, and manufacturing personnel. Support competency assessments and qualification of personnel performing microbiological activities. 

Education and Experience

• Education: Minimum of a bachelor’s degree in microbiology, Biology, or a related scientific field.
• Experience: Relevant experience in a GMP-regulated microbiology laboratory, preferably within the dietary supplement, food, or pharmaceutical manufacturing industries.
• Skills: Strong analytical, problem-solving, and critical thinking skills. Excellent attention to detail, organizational skills, and the ability to communicate technical information effectively, both verbally and in writing.
  

Physical/Work Environment/Expectations