Microbiologist

Microbiologist

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.

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.

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.

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.

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.

Skills & Ability Level 1. Level 2,and Level 3:

NOTE: The ability to maintain integrity and honesty at all time and communicate with transparency.

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 of 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