North Brunswick
Job Description Job Description Date 2026 Location 1200 Airport Road, North Brunswick NJ Title Microbiologist - 1, 2 & 3 Department Quality Control Reports to Manager, Microbiology Laborator FLSA (Exempt or Non-Exempt Exempt Role Overview The Microbiology team is responsible for performing and overseeing microbiological testing of raw materials, finished products, stability samples, water, and environmental monitoring samples to ensure product quality, safety, and compliance with applicable USP requirements, cGMP, and company procedures. Microbiologist I, Microbiologist II and Microbiologist III, represent progressive levels of technical expertise, independence, and responsibilities. Each level contributes to maintaining data integrity, supporting continuous improvement, and ensuring accurate, reliable, and timely laboratory results. Areas of Responsibility MICROBIOLOGIST I NOTE: This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice. The company reserves the right to modify, interpret, or append this job description at any time The Microbiologist I performs routine microbiological testing of raw materials, finished products, stability samples, water samples, and environmental monitoring samples in accordance with approved USP methods, company SOPs, and applicable regulatory requirements. This position focuses on developing foundational laboratory skills, maintaining accurate documentation, and demonstrating proficiency in routine microbiological testing under appropriate supervision. • Perform routine Microbial Limit Testing using aseptic technique and in accordance with applicable USP methods and approved SOPs., • Perform daily balance weight checks., • Perform weekly pipette calibration., • Monitor and record daily temperature and humidity logs for laboratories., • Monitor and record daily temperature logs for laboratory equipment., • Ensure all laboratory equipment is properly maintained and calibrated., • Conduct routine microbial enumeration testing, including Total Aerobic Microbial Count (TAMC), Total Count Yeast and Mold (TYMC), and other applicable microbiological tests., • Assist with microbiological testing of raw materials, finished products, and stability samples., • Conduct environmental monitoring activities in production and microbiology laboratory areas., • Perform environmental monitoring sample collection and testing, as assigned., • Sampling and microbial testing of nitrogen gas., • Prepare microbiological media and perform growth promotion testing for in-house and purchased media according to approved procedures., • Assist with cleaning validation sample collection and analysis., • Operate Neogen Soleris rapid microbial testing systems as applicable and after training., • Record sample information, test results, and observations in laboratory logbooks, controlled data sheets, and approved electronic systems., • Maintain complete, accurate, and traceable records in accordance with Good Documentation Practices (GDP)., • Identify and promptly report unexpected, potentially out-of-specification (OOS), or out-of-trend (OOT) results to QC management., • Assist with laboratory investigations by providing supporting records and data, as directed., • Maintain laboratory cleanliness, equipment readiness, proper waste disposal, and compliance with safety and contamination-control requirements., • Support internal audits, customer audits, and regulatory inspections by maintaining organized laboratory records., • Manage laboratory supplies including but not limited to media, reagents, and PPE., • Complete all required technical, cGMP, GDP, and safety training., • Must be able to work extended hours as needed and occasional weekends., • Perform other duties and responsibilities as assigned by QC management. MICROBIOLOGIST II The Microbiologist II independently performs routine and moderately complex microbiological testing of raw materials, finished products, stability samples, water samples, and environmental monitoring samples. This position demonstrates technical proficiency in conventional and rapid microbiological methods, supports method suitability and verification activities, assists with laboratory investigations, and provides guidance to junior microbiologists. These responsibilities are in conjunction with responsibilities listed above. • Independently perform Microbial Limit Testing in accordance with applicable USP requirements and approved SOPs., • Conduct microbial enumeration and contaminant testing of raw materials, finished products, and stability samples., • Perform routine TAMC, TYMC, and other applicable microbiological tests., • Conduct environmental monitoring activities in production and microbiology laboratory areas., • Perform USP water sampling and microbiological testing, as assigned., • Operate and troubleshoot routine testing activities using Neogen Soleris and other approved rapid microbial testing systems., • Prepare microbiological media and perform growth promotion testing for in-house and purchased media according to approved procedures., • Perform cleaning validation sample collection, analysis, and documentation., • Perform USP water sampling and microbiological testing., • Perform method suitability, method verification, and basic method validation activities under approved protocols., • Assist with developing and revising microbiological test procedures, worksheets, and laboratory documentation., • Review personal testing records and verify calculations, data completeness, traceability, and compliance with GDP., • Enter and verify sample information and results in laboratory automation programs and electronic systems., • Identify, document, prepare, and escalate OOS, OOT, atypical, and invalid results., • Participate in laboratory investigations by compiling data, reviewing testing records, and supporting root-cause assessments and CAPA activities., • Assist with laboratory audits, customer audits and requests, and regulatory inspections., • Train Microbiologist I personnel on routine testing, laboratory safety, and documentation practices as assigned., • Identify opportunities to improve laboratory efficiency, data integrity, and testing workflows., • Collaborate with Quality Control, Quality Assurance, and other departments to resolve routine and complex microbiological testing issues., • Maintain compliance with cGMP, GDP, 21 CFR Part 11, and applicable internal procedures., • Perform other duties and responsibilities as assigned by QC management. MICROBIOLOGIST III Microbiologist III performs advanced and complex microbiological testing and serves as a technical resource for laboratory operations. This position executes assigned method suitability, verification, and validation activities; reviews laboratory data; supports investigations; troubleshoots technical issues; and trains and mentors junior microbiologists. The position also supports method suitability testing, total probiotic enumeration, environmental monitoring, technical documentation, and continuous improvement initiatives. • Perform complex microbiological testing of raw materials, finished products, stability samples, water samples, and environmental monitoring samples., • Execute Microbial Limit Testing, microbial enumeration, and applicable contaminant testing using approved USP, published, and internal methods., • Perform and troubleshoot rapid microbial testing using Neogen Soleris, and other approved systems., • Execute method suitability, verification, and validation protocols in accordance with approved procedures., • Support method development activities for microbial enumeration, probiotic testing, and contamination assessment, as applicable., • Perform USP water sampling and microbiological testing., • Conduct environmental monitoring activities and support program maintenance, trend review, and investigation of abnormal results., • Prepare microbiological media and perform growth promotion testing for in-house and purchased media according to approved procedures., • Collect, test, and evaluate cleaning validation samples according to approved protocols., • Review laboratory data, calculations, worksheets, logbooks, and electronic records for completeness, accuracy, and compliance., • Prepare technical summaries and reports and review assigned microbiological results within delegated authority., • Investigate and troubleshoot OOS, OOT, atypical, and invalid results in collaboration with QC management and Quality Assurance., • Support root-cause analysis, CAPA implementation, and follow-up effectiveness activities as assigned., • Assist in developing, reviewing, and updating SOPs, laboratory methods, validation protocols, and technical reports., • Identify microbiological trends, recurring testing issues, and opportunities for preventive action., • Train and mentor Microbiologist I and II personnel in aseptic testing techniques, documentation, safety, and laboratory procedures., • Provide technical support for laboratory equipment, rapid testing system
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