Microbiologist

US Pharma Lab • North Brunswick Township, NJ

11d • $68,000 - $105,000 • Onsite

About The Position

The Microbiologist works in the Quality Control department and performs microbiological testing of raw materials, finished products, stability samples, water, and environmental monitoring samples to support product quality, safety, and compliance with applicable USP requirements, cGMP, and company procedures. The role has three progressive levels—Microbiologist I, II, and III—with increasing technical expertise, independence, and responsibility. Across levels, the position contributes to data integrity, continuous improvement, and accurate, reliable, and timely laboratory results.

Microbiologist I performs routine testing under appropriate supervision, develops foundational laboratory skills, and maintains accurate documentation. Microbiologist II independently performs routine and moderately complex testing, supports method suitability and verification, assists with investigations, and guides junior microbiologists. Microbiologist III performs advanced and complex testing, executes method suitability, verification, and validation activities, reviews data, troubleshoots technical issues, supports investigations, and trains and mentors junior staff.

The work is regularly performed in a laboratory, with some work at a bench, and may also involve a standard office environment. The laboratory may involve exposure to chemicals, cleaning agents, dust, odors, noise, and fumes. The position requires use of personal protective equipment and may require extended hours as needed and occasional weekends. The role reports to the Manager, Microbiology Laboratory.

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 Levels I and II and specified for Level III.
• Demonstrated proficiency in routine microbiological testing for Level II.
• Experience with method suitability, verification, validation, or complex microbiological testing is preferred for Level III.
• Ability to troubleshoot testing issues and provide technical guidance to junior personnel for Level III.
• Basic understanding of microbiological laboratory techniques and aseptic practices; working or advanced working knowledge of USP microbiological methods, microbial enumeration, environmental monitoring, and contamination testing as appropriate to the level.
• Familiarity or working knowledge of cGMP, GDP, data integrity, and 21 CFR Part 11, as appropriate to the level.
• Ability to follow written procedures and maintain accurate laboratory records, recognize or escalate abnormal results, and work independently at the level required.
• Proficiency in Microsoft Word, Excel, and applicable electronic laboratory data-entry or automation systems.
• Strong attention to detail, organization, time management, communication, analytical thinking, and problem-solving skills appropriate to the level.
• Ability to train or mentor junior personnel at Levels II and III.
• Ability to prioritize assigned testing activities and meet deadlines.
• Ability to maintain integrity and honesty and communicate transparently.
• Ability to navigate office, laboratory, and plant-floor environments; use hands to handle or operate objects and controls; bend, squat, walk short distances, lean over equipment, kneel, and lift up to 20 pounds on occasion.
• Ability to wear required PPE, including a lab coat, face mask, booties, gloves, safety glasses or goggles, and respirators.

Nice To Haves

• Basic microbiological laboratory experience for Microbiologist I.
• Previous QC laboratory experience in dietary supplements, food, OTC, pharmaceutical, or other regulated manufacturing environments for Microbiologist I and II.
• A master’s degree for Microbiologist III.
• Practical experience with conventional microbiological methods and rapid microbial testing systems for Microbiologist II.
• Experience with method suitability, verification, validation, or complex microbiological testing for Microbiologist III.

Responsibilities

• Perform routine, moderately complex, or advanced microbiological testing of raw materials, finished products, stability samples, water, and environmental monitoring samples, according to assigned level.
• Perform Microbial Limit Testing, microbial enumeration, including TAMC and TYMC, and applicable contaminant testing using approved USP, published, and internal methods.
• Perform environmental monitoring activities and sample collection in production and microbiology laboratory areas; support program maintenance, trend review, and investigation of abnormal results as applicable.
• Collect and perform USP water and nitrogen gas sampling and microbiological testing as assigned.
• Prepare microbiological media and perform growth promotion testing for in-house and purchased media.
• Collect, analyze, and document cleaning validation samples according to approved procedures and protocols.
• Operate and troubleshoot Neogen Soleris and other approved rapid microbial testing systems, as applicable to the assigned level.
• Perform method suitability, verification, validation, and method development activities in accordance with approved protocols and procedures, as assigned.
• Maintain laboratory equipment, perform daily balance weight checks and weekly pipette calibration, and record laboratory and equipment temperature and humidity readings.
• Record and review sample information, test results, calculations, observations, worksheets, logbooks, and electronic records for accuracy, completeness, traceability, and compliance with GDP.
• Identify, document, and escalate OOS, OOT, atypical, invalid, or otherwise unexpected results; support investigations, root-cause analysis, and CAPA activities.
• Prepare technical summaries and reports, review assigned results within delegated authority, and assist with laboratory methods, SOPs, validation protocols, worksheets, and other technical documentation.
• Train and mentor junior microbiologists and provide technical guidance on testing, aseptic techniques, safety, and documentation practices as assigned.
• Maintain laboratory cleanliness, equipment readiness, proper waste disposal, and compliance with safety and contamination-control requirements.
• Manage laboratory supplies, including media, reagents, and PPE.
• Support internal and customer audits and regulatory inspections by maintaining, preparing, and reviewing laboratory records and documentation.
• Collaborate with Quality Control, Quality Assurance, production, and other departments to resolve microbiological testing issues.
• Identify opportunities to improve laboratory efficiency, data integrity, testing workflows, and microbiological practices.
• Complete required technical, cGMP, GDP, and safety training, and keep management informed of area activities and significant problems.
• Work extended hours as needed and occasional weekends.
• Perform other duties and responsibilities as assigned by QC management.

Benefits

• Medical, dental, and vision benefit options.
• Short-term and long-term disability insurance.
• Basic and supplemental life insurance.
• AD&D insurance.
• Matched 401(k) savings plan.
• Potential premium pay, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level