Microbiologist

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. 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 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 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 elevate 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 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 systems, and troubleshooting of analytical issues. Support customer audits, internal audits, and regulatory inspections by preparing and reviewing laboratory documentation. Coordinate assigned technical activities and communicate project status, testing delays, and significant issues to QC management. Collaborate with Quality Control, Quality Assurance, production, and other departments to resolve complex microbiological issues. Ensure compliance with cGMP, GDP, applicable USP requirements, 21 CFR Part 11, and approved company procedures. Perform other duties and responsibilities as assigned by QC management. Other Responsibilities Including Safety: Level 1. Level 2,and Level 3. Works in a safe and responsible manner to create an injury‑free and incident‑free workplace. Complies with all job‑related safety and other training requirements. Keeps management informed of area activities and of any significant problems. Requirements Education & Qualification: MICROBIOLOGIST I Bachelor's degree in microbiology, Biology, Chemistry, or a related scientific discipline. Basic microbiological laboratory experience preferred; approximately 1 year of relevant experience is desirable. Previous QC laboratory experience in dietary supplements, food, OTC, pharmaceutical, or other regulated Manufacturing environments is preferred. MICROBIOLOGIST II Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific discipline. Approximately 2–4 years of relevant microbiology laboratory experience preferred. QC laboratory experience in dietary supplements, food, OTC, pharmaceutical, or other regulated manufacturing environments preferred. Demonstrated proficiency in routine microbiological testing. MICROBIOLOGIST III Bachelor's degree in Microbiology or a related scientific discipline required; a master's degree preferred. Approximately 3–5+ years of relevant microbiology laboratory experience preferred. QC laboratory experience in dietary supplements, food, OTC, pharmaceutical, or other regulated manufacturing environments. Experience with method suitability, verification, validation, or complex microbiological testing preferred. Demonstrated ability to troubleshoot testing issues and provide technical guidance to junior personnel. Certifications, Licenses, Credentials: N/A Skills Skills & Ability Level 1. Level 2,and Level 3: NOTE: The ability to maintain integrity and honesty at all time and communicate with transparancy. Level I Basic understanding of microbiological laboratory techniques and aseptic practices. Familiarity with USP methods, cGMP, GDP, and 21 CFR Part 11 preferred. Basic proficiency in Microsoft Word, Excel, and electronic laboratory data‑entry systems. Ability to follow written procedures and maintain accurate laboratory records. Strong attention to detail, organization, and time management. Ability to communicate testing results and laboratory concerns promptly. Ability to work independently on assigned tasks while seeking guidance when needed. Level II Working knowledge of USP microbiological methods, microbial enumeration, environmental monitoring, and contamination testing. Practical experience with conventional microbiological methods and rapid microbial testing systems preferred. Working knowledge of cGMP, GDP, data integrity, and 21 CFR Part 11. Ability to identify routine testing issues and troubleshoot within approved procedures. Ability to review laboratory records and recognize abnormal results. Proficiency in Microsoft Word, Excel, and applicable laboratory data systems. Strong documentation, communication, organization, and time‑management skills. Ability to train junior personnel on established methods and procedures. Ability to manage assigned testing activities independently and meet deadlines. Level III Advanced working knowledge of USP microbiological methods, microbial enumeration, environmental monitoring, and contamination testing. Experience with rapid microbial testing systems and method verification or suitability activities. Strong understanding of cGMP, GDP, data integrity, and 21 CFR Part 11. Ability to review and interpret microbiological data and recognize technical or documentation discrepancies. Working knowledge of OOS/OOT handling, laboratory investigations, root‑cause analysis, and CAPA. Ability to prepare and review protocols, reports, and technical documentation. Strong analytical thinking, troubleshooting, and problem‑solving skills. Ability to train and mentor junior staff and coordinate assigned technical activities. Proficiency in Microsoft Word, Excel, and laboratory automation systems. Ability to work independently, prioritize multiple assignments, and meet project deadlines. Career Development and Promotion Criteria To progress to Microbiologist II, the employee is expected to demonstrate: Proactively address any issues, corrective actions or continuous improvement opportunities to ensure optimal performance of the microbiology department. Proficiency in assigned routine microbiological testing methods. Consistent adherence to approved SOPs, laboratory safety requirements, and documentation practices. Ability to complete routine testing with reduced supervision. Appropriate recognition and escalation of abnormal or unexpected results. Successful completion of required training and competency assessments. Consistent accuracy, reliability, and timely completion of assigned work. Next career level: Microbiologist II – Independent Routine Testing. To progress to Microbiologist III, the employee is expected to demonstrate: Proactively address any issues, corrective actions or continuous improvement opportunities to ensure optimal performance of the microbiology department. Evaluate technical problems from multiple perspectives to identify and suggest alternative solutions for improvement opportunities. Consistent independent performance of routine and moderately complex microbiological tests. Proficiency in rapid microbial testing systems and assigned specialized methods. Ability to troubleshoot testing issues and provide appropriate investigation support. Demonstrated understanding of method suitability, verification, and validation principles. Strong data review, documentation, and regulatory compliance practices. Ability to train junior employees and support technical knowledge transfer. Successful completion advanced competency assessments and assigned technical projects. Next career level: Microbiologist III – Advanced Testing and Technical Support. To progress to Senior Microbiologist, the employee is expected to demonstrate: Advanced proficiency in complex microbiological testing and troubleshooting. Independent execution and evaluation of method suitability, verification, or validation studies. Ability to develop or substantially contribute to technical protocols, reports, and method improvements. Strong technical judgment in evaluating abnormal results and supporting investigations. Demonstrated ability to review data, interpret trends, and recommend corrective or preventive actions. Proven ability to train and mentor laboratory personnel. Successful ownership of assigned technical projects and consistent delivery of high‑quality results. Demonstrated readiness to serve as a technical subject‑matter resource for the microbiology team. Physical Requirements (lifting, Etc.) Ability to navigate office, lab, and/or plant floor working environments. Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances and leaning over equipment as well as kneeling on the floor to clean under the equipment. Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators. On occasion may need to lift up to 20lbs Work Environment (Office, Warehouse, Temperature Extremes, Etc.) Work is regularly performed inside a laboratory environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents. May execute up to 20% of their work at the bench level either standing or sitting on a stool. Work performed in a standard office environment is without unpleasant or hazardous conditions. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including: medical, dental, vision, short and long term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation the first year, which grows to 12 days starting the second year of employment. Job Description Acknowledgement I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodation. #J-18808-Ljbffr US Pharma Lab, Inc.