Job Description
1200 Airport Road, North Brunswick NJ
Manager, Quality Control Microbiology
FLSA (Exempt or Non-Exempt
The Senior Microbiologist performs compendial, published / customer provided methods and rapid microbial methods (using Biolumix / Soleris systems) for enumeration testing of finished products and raw materials. Also, create & execute the validation and suitability protocols for developed methods as per USP & ISO guidelines so that methods can be used for routine analysis in microbiology lab.
The duties and responsibilities described for each level are not limited to those outlined and are not intended to be a comprehensive list of all activities, functions, or responsibilities required of the position. Management reserves the right to modify, assign, or reassign duties and responsibilities at any time based on business needs.
- Under the supervision of Quality Control Microbiology Manager and Lead Microbiologist, carry out activities in support of developing new methods for enumeration of probiotic strains, methods suitability of dietary supplement products using rapid and conventional techniques.
- Creation of method validation/verification protocol for new methods for enumeration and contaminants estimation.
- Perform USP water sampling and testing using rapid micro technology & USP methodology.
- Perform identification of microorganisms as per USP general chapters / AOAC published method.
- Perform enumeration, non-lactic bacteria and microbial contaminants testing in the raw materials, finished products and stability samples, for routine samples.
- Media preparation & Growth promotion testing to be performed for new method development / verification.
- Maintain notebooks & lab records within GMP standards and as per USPL SOPs & guidelines. Accurately report results and provide detailed records of results and conclusions.
- Assist in creating protocol for Soleris rapid micro system method suitability.
- Assist other microbiologists, as necessary, for timely project completion and support other lab personnel as required.
- Comply with Health, Safety and Environmental responsibilities for the position.
- Train newly joined microbiologist to perform testing for enumerations of probiotics and to perform routine tests for TAC, YM, pathogens using rapid microbial techniques of Neogen Soleris system and USP conventional methods.
- ATCC Culture identification and population verifications.
- Performs transactions for sample entry and results recording.
- Follow all the USPL SOPs to work in the microbiology lab, including gowning, safety, waste disposal of Biohazard materials, and general written guidelines.
- Recognizes OOS or out of-trend and, under the direction of QC management, assists in lab investigations.
- Documentation of generated microbial lab related data as per GDP and recovery of stored documents within stipulated time during GMP audits or requested by customer.
- Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, GLP, and documentation) when performing the assigned activity.
- Must be able to work extended hours as needed and occasional weekends.
- Other duties and responsibilities as assigned by QC management.
Other Responsibilities Including Safety:
- 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.
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Education & Qualification:
- MS in Microbiology or microbiology related scientific disciplines.
- 5+ years in microbiology laboratory techniques
- Minimum of 5 years QC lab work experience with industry experience in dietary supplements, food, or OTC manufacturing.
Certifications, Licenses, Credentials:
Skills & Ability
- Ability to maintain integrity and honesty at all times and to communicate with transparency.
- Ability to work independently or as part of a team.
- Solid understanding of cGMP’s and GLP and is familiar with 21 CFR Part 11
- Strong working knowledge of Microsoft Word, Excel.
- Good documentation practice and able to write simple, clear reports.
- Meets commitments on time and practices time-management skills.
- Seeks to identify continuous improvement needs.
- Experience with rapid microbial testing procedures is an advantage.
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.
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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.
