What are the responsibilities and job description for the Senior, Microbiologist position at USPL NUTRITIONALS LLC?

Job Description

Date

01 / 2024

Location

1200 Airport Road, North Brunswick NJ

Title

Senior, Microbiologist

Department

Quality Control

Reports to

Manager, Quality Control Microbiology

FLSA (Exempt or Non-Exempt

Exempt

Role Overview

The Senior Microbiologist performs compendial and rapid microbial testing (using Biolumix / Soleris systems) of finished products and raw materials and also environmental monitoring program of production, packaging and Microbiology area.

Areas of Responsibility

Under the supervision of Microbiology Manager or Lead Microbiologist, carry out activities in support of the manufacturing of dietary supplement products. These activities include compendia! microbial testing of raw materials, in process materials, finished products within scheduled timelines.
Perform environmental sampling and testing as per SOP and testing procedures.
Perform USP water sampling and testing using rapid micro technology & USP methodology.
Perform identification of microorganisms as per USP general chapters.
Perform enumeration, non-lactic bacteria and microbial contaminants testing in probiotic raw materials, finished products and stability samples.
Media preparation & Growth promotion testing.
Maintain notebooks within GMP standards and SOPs. Accurately report results and provide detailed records of results and conclusions.
Provides written and verbal updates on projects and activities as required.
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.
Review of all microbial data, approval of microbial results & reports.
Collection and analysis of cleaning validation samples.
ATCC Culture identification and population verifications.
Performs transactions for sample entry and results recording.
Performs method suitability, verification, and validation for microbiological methods where applicable.
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.
Other duties and responsibilities as assigned by Micrology Manager or QC Director.

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.

Requirements

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 :

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 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.

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.

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