QC Microbiologist

Balchem is committed to making the world a healthier place by delivering trusted, innovative, and science-based solutions for health and nutritional needs. With approximately 1,400 employees worldwide, Balchem provides service, quality, and technology that enables customers to succeed. Founded in 1967 and publicly traded on Nasdaq (BCPC), the company operates three business segments: Human Nutrition and Health, Animal Nutrition and Health, and Specialty Products.

About the role

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. Contribute to Balchem’s network microbiological problem-solving for environmental monitoring (EM) and product testing.

Responsibilities

• 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 dietary supplement and food applications
• Specify and ensure satisfactory outcome of 3rd party proficiency testing
• Train and provide guidance to laboratory personnel
• Perform data verification, interpretation, and analysis
• Operate, maintain, calibrate, and repair microbiology laboratory instruments and equipment
• Inspect/audit lab activities and data to ensure implementation of quality systems
• Provide backfill coverage in all other lab positions and contribute experience and scientific knowledge
• Perform mathematical and statistical analyses of results
• Develop and formalize laboratory procedures and practices
• Write laboratory reports, protocols, SOPs, and work instructions
• Ensure audit preparedness for the microbiology lab
• Assist with audits of 3rd-party microbiology lab service providers
• Other duties as assigned

Requirements

• Bachelor’s 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, and gases
• MSDS reference for hazardous materials
• Occasional work in production facility with exposure to dust, heat, and stairways