Microbiologist

USPL NUTRITIONALS•North Brunswick, NJ

12d•Onsite

About The Position

The Microbiologist role has three progressive levels—Microbiologist I, II, and III—within the Quality Control department. The team performs and oversees microbiological testing of raw materials, finished products, stability samples, water, and environmental monitoring samples to help ensure product quality, safety, and compliance with applicable USP requirements, cGMP, and company procedures. All levels contribute to data integrity, continuous improvement, and the delivery of accurate, reliable, and timely laboratory results. Microbiologist I performs routine testing under appropriate supervision while developing foundational laboratory skills. Microbiologist II independently performs routine and moderately complex testing, supports method suitability and verification activities, assists with investigations, and guides junior microbiologists. Microbiologist III performs advanced and complex testing, serves as a technical resource, reviews data, troubleshoots issues, supports investigations, executes assigned suitability, verification, and validation activities, and trains and mentors junior staff. The position is based at 1200 Airport Road, North Brunswick, New Jersey. Work is regularly performed in a laboratory, with some work in an office and potentially on a plant floor. The laboratory may involve exposure to chemicals, cleaning agents, dust, odors, noise, and fumes. Employees must use required personal protective equipment. Extended hours may be needed, and occasional weekend work is required. The position is classified as exempt.

Requirements

Bachelor’s degree in microbiology, biology, chemistry, or a related scientific discipline; a bachelor’s degree in microbiology or a related scientific discipline is required for Microbiologist III.
Approximately 1 year of relevant experience is desirable for Microbiologist I; approximately 2–4 years is preferred for Microbiologist II; approximately 3–5+ years is preferred for Microbiologist III.
QC laboratory experience in dietary supplements, food, OTC, pharmaceutical, or other regulated manufacturing environments is preferred for Microbiologist I and II and specified for Microbiologist III.
Demonstrated proficiency in routine microbiological testing for Microbiologist II.
Ability to follow written procedures and maintain accurate laboratory records.
Basic understanding of microbiological laboratory techniques and aseptic practices for Microbiologist I; advanced working knowledge of USP microbiological methods, microbial enumeration, environmental monitoring, and contamination testing for Microbiologist III.
Working knowledge of USP microbiological methods, microbial enumeration, environmental monitoring, and contamination testing for Microbiologist II.
Experience with conventional microbiological methods and rapid microbial testing systems is preferred for Microbiologist II; experience with rapid microbial testing systems and method verification or suitability activities is expected for Microbiologist III.
Familiarity with USP methods, cGMP, GDP, and 21 CFR Part 11 is preferred for Microbiologist I; working knowledge is specified for Microbiologist II and a strong understanding is specified for Microbiologist III.
Ability to review and interpret microbiological data, recognize abnormal results and technical or documentation discrepancies, and identify or troubleshoot testing issues within approved procedures.
Working knowledge of OOS/OOT handling, laboratory investigations, root-cause analysis, and CAPA for Microbiologist III.
Ability to prepare and review protocols, reports, and technical documentation for Microbiologist III.
Proficiency in Microsoft Word, Excel, and applicable laboratory data-entry, automation, or electronic systems appropriate to the level.
Strong attention to detail, organization, time management, communication, documentation, analytical thinking, troubleshooting, and problem-solving skills appropriate to the level.
Ability to work independently on assigned tasks, manage multiple assignments, meet deadlines, and seek guidance when needed.
Ability to train junior personnel on established methods and procedures for Microbiologist II, and train and mentor junior staff and coordinate assigned technical activities for Microbiologist III.
Ability to maintain integrity and honesty and communicate transparently.
Ability to navigate office, laboratory, and/or plant-floor environments; handle or operate objects and controls; bend, squat, walk short distances, lean over equipment, and kneel to clean beneath equipment.
Ability to wear required PPE, including a lab coat, face mask, booties, gloves, safety glasses or goggles, and respirators.
Ability to lift up to 20 pounds on occasion.

Nice To Haves

Basic microbiological laboratory experience for Microbiologist I.
QC laboratory experience in dietary supplements, food, OTC, pharmaceutical, or other regulated manufacturing environments for Microbiologist I and II.
Master’s degree for Microbiologist III.
Experience with method suitability, verification, validation, or complex microbiological testing for Microbiologist III.

Responsibilities

Perform routine or complex microbial limit, enumeration, contaminant, and other microbiological testing of raw materials, finished products, stability samples, water, and environmental monitoring samples, according to assigned level and approved procedures.
Conduct environmental monitoring in production and laboratory areas, including sample collection, testing, program support, trend review, and investigation of abnormal results as assigned.
Perform USP water sampling and microbiological testing as assigned.
Prepare microbiological media and perform growth promotion testing for in-house and purchased media.
Operate and troubleshoot Neogen Soleris and other approved rapid microbial testing systems, as applicable to the role and training.
Perform cleaning validation sample collection, analysis, evaluation, and documentation according to approved protocols.
Perform routine laboratory checks, including balance weight checks, pipette calibration, and monitoring and recording laboratory and equipment temperature and laboratory humidity.
Maintain laboratory equipment, cleanliness, readiness, waste disposal, supplies, and compliance with safety and contamination-control requirements.
Record and maintain complete, accurate, traceable sample information, results, calculations, observations, and other laboratory records in logbooks, controlled forms, and approved electronic systems.
Review laboratory data and records for accuracy, completeness, traceability, and compliance with good documentation practices.
Identify, document, report, and escalate unexpected, out-of-specification, out-of-trend, atypical, and invalid results; support or conduct investigations, root-cause assessments, and CAPA activities as assigned.
Perform or support method suitability, verification, validation, and method development activities under approved procedures and protocols, according to assigned level.
Assist in developing, reviewing, and revising microbiological procedures, worksheets, SOPs, methods, protocols, technical reports, and other laboratory documentation.
Prepare technical summaries and reports and review assigned microbiological results within delegated authority, as applicable.
Train and mentor junior microbiologists in testing, aseptic technique, laboratory safety, documentation, and established procedures, as assigned.
Identify opportunities to improve laboratory efficiency, data integrity, testing workflows, and preventive actions.
Support internal and customer audits and regulatory inspections by preparing, organizing, maintaining, and reviewing laboratory records and documentation.
Collaborate with Quality Control, Quality Assurance, production, and other departments to resolve routine and complex microbiological testing issues.
Communicate testing delays, project status, significant issues, and laboratory concerns to QC management.
Complete required technical, cGMP, GDP, and safety training; follow applicable USP requirements, 21 CFR Part 11, company procedures, and safety requirements.
Work extended hours as needed and occasional weekends.
Perform other duties and responsibilities as assigned by QC management.

Benefits

Medical insurance
Dental insurance
Vision insurance
Short- and long-term disability insurance
Basic and supplemental life insurance
AD&D insurance
Matched 401(k) savings plan
Premium pay opportunities, including overtime, shift differential, and holiday pay
Sick time
Up to 10 days of vacation in the first year, increasing to 12 days starting in the second year