QC Microbiologist

COMPANY OVERVIEW:

Balchem is committed to making the world a healthier place by delivering trusted, innovative, and science-based solutions for the health and nutritional needs of the world. Balchem employs approximately 1,400 employees worldwide who provide the service, quality, and technology that enables our customers to win with their customers. We have built a reputation for delivering results to all of our stakeholders. Founded in 1967, Balchem, a Maryland corporation, became a publicly traded company in 1970 and is listed on Nasdaq under the symbol BCPC. Our corporate headquarters is located in Montvale, New Jersey, and we have a broad network of sales offices, manufacturing sites, and R&D centers, primarily located in the U.S. and Europe. The Company consists of three business segments: Human Nutrition and Health, Animal Nutrition and Health, and Specialty Products.

POSITION SUMMARY:

Perform and manage the day-to-day microbiological testing of raw materials and finished goods. Assist in risk evaluations for microbiological hazards as a member of the food safety team. Assist in the management and maintenance of the environmental monitoring program, and other associated testing in the laboratory. Contribute to Balchem network microbiological problem solving for environmental monitoring (EM) and product testing.

ESSENTIAL FUNCTIONS:

• Microbiological testing and release/rejection of raw materials and finished products

• Collect, analyze, and monitor environmental samples, and manage each program. Revise and update EM programs as needed

• Perform OOS investigation and root cause analysis for out of specification and out of trend results

• Develop and validate microbiological methods for use in dietary supplement and food applications

• Responsible for specifying and ensuring satisfactory outcome of 3rd party proficiency testing

• Train and provide guidance to laboratory personnel

• Perform data verification, interpretation, and analysis

• Responsible for the operation, maintenance, calibration and repair of microbiology laboratory instruments and equipment

• Inspect/audit lab activities and data to ensure implementation of quality systems

• Provide back fill coverage in all other lab positions and contribute experience and scientific knowledge

• Perform mathematical and statistical analyses of results

• Developing and formalize laboratory procedures and practices

• Write laboratory reports, protocols, SOPs and work instructions

• Ensure audit preparedness for the microbiology lab

• Assist with audit of 3rd microbiology lab services providers

• Other duties as assigned

REQUIREMENTS:

• Bachelors degree in Microbiology or closely related field

• 2-4 years of experience in a cGMP microbiology laboratory

• Experience with microbiological assays and aseptic techniques; familiarity with cGMPs, FDA guidelines, and good laboratory practices

• Environmental Monitoring Program training and experience preferred

• In depth knowledge of USP, AOAC, FDA BAM microbiological testing methods

• Knowledge of allergen testing methods

• Knowledge of ISO 17025 requirements

WORKING CONDITIONS:

• Works inside a laboratory, subject to fumes, odors, gases

• MSDS reference for hazardous materials

• Occasional work in production facility with exposure to dust, heat and stairways

Balchem is committed to a workplace culture that values and promotes diversity, inclusion, equal employment opportunities, and a work environment free of harassment and hostility.