Senior, Microbiologist

Senior Microbiologist

Date - 01/2024 - Location - 1200 Airport Road, North Brunswick NJ

Reports to
- Manager, Quality Control Microbiology - FLSA (Exempt or Non-Exempt
- Exempt

Role Overview

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.

Areas of Responsibility

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.

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.):
Abil…