Job Description

Date

06/25

Location

1300 Airport Road, North Brunswick NJ

Title

Lead, Microbiologist

Department

Quality Control

Reports to

Director Quality Control

FLSA (Exempt or Non-Exempt)

Exempt

Role Overview

The Lead Microbiologist performs rapid microbial testing of finished products and raw materials using Biolumix / Soleris is an additional advantage, environmental monitoring program of production and Microbiology area.

Areas of Responsibility

• Preparation of methods for Microbial Limit tests as per USP, when required testing of samples as per these methods
• Rapid microbial testing of finished products and raw materials using Biolumix / Soleris
• Review of all microbial data, approval of microbial results & reports
• Creation & execution of Environmental monitoring program of production and Microbiology area
• Media preparation & Growth promotion testing
• Collection and analysis of Cleaning validation samples
• ATCC Culture identification and population verifications
• Recording of testing and results in appropriate logbooks and lab automation programs.
• Performs transactions for sample entry and results recording
• Performs miscellaneous validation for basic microbiological methods where applicable
• Compiles all data obtained from testing and observations and completes report summaries.
• 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
• Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP,GLP, documentation) when performing the assigned activity.
• Must be able to work extended hours as needed and occasional weekends.
• Works in a safe and responsible manner in order to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements.
• Other duties as assigned

Requirements

Education & Qualification:

• BA Science or related scientific disciplines
• Minimum of 5-10 years QC lab work experience with industry experience in dietary supplements, food or OTC manufacturing.

Certifications, Licenses, Credentials:

• N/A

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 practices 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.
• Physical demands involved in office work such as the ability to talk, hear, use hands to handle and feel; work on a computer up to 7 hours a day; close vision required for computer usage.
• 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.

Office hours:
8:30 AM - 5:00 PM
9:00 AM - 5:30 PM