Quality Assurance Coordinator

Balchem Corporation develops, manufactures, and markets specialty ingredients that improve and enhance the health and well-being of life on the planet. With headquarters in Montvale, New Jersey, Balchem operates a global network of sales offices, manufacturing sites, and R&D centers, primarily in the US and Europe. Founded in 1967, the company is publicly traded (NASDAQ – “BCPC”) with annual revenues over $900 million and a market cap exceeding $4.0 billion. Balchem employs over 1,400 people worldwide across three business segments: Human Nutrition & Health; Animal Nutrition & Health; and Specialty Products.

About the Role

Under the direction of the Quality Manager, provide support for quality system activities to ensure conformance to established specifications and compliance with FDA 21 CFR 117 regulation and third-party certification standards, including SQF. Work on projects related to external regulations, agency guidelines, and internal policies to assure compliance. Facilitate the optimization and continuous improvement of internal quality systems to meet department and company objectives.

Responsibilities

• Support supply chain delivery through day-to-day activities such as release, testing, reviewing, troubleshooting, and completing verifications, validations, and calibrations.
• Ensure execution of food safety and third-party requirements, including auditing, performance tracking, and KPI management.
• Prioritize and escalate non-conformances, assign corrective and preventive actions (CAPA), and drive root cause analysis.
• Identify operational excellence opportunities and execute improvement initiatives.
• Contribute to quality commercialization reviews, including specification reviews.
• Manage escalated issues, including internal defects, external complaints, and CAPA investigations with effectiveness checks.
• Support operational excellence and continuous improvement activities, including internal audits and cross-functional team development.
• Partner with site leaders for goal setting, decision-making, training, and development needs.
• Coordinate completion of MSS, record reviews, verifications, and calibrations.
• Provide backup support for departmental functions and deploy quality strategies across the site.
• Develop and performance-manage the site quality laboratory team.
• Build cross-functional relationships and influence site strategy and execution.
• Deliver and maintain training programs focused on food safety and quality.
• Escalate and communicate food safety, quality, and financial issues in a timely manner.
• Ensure effective application of site Product Safety, Product Quality, and prerequisite systems.
• Apply root cause analysis to prevent recurrence of issues through engineering, formula, or elimination strategies.
• Collaborate with R&D, Production, and commercial teams for new product, process, and equipment development.
• Coordinate with operational excellence programs and prepare for customer visits and external audits.
• Serve as a site power user for ERP & LIMS systems.

Requirements

• Bachelor’s degree in a science-related field or relevant experience.
• 1+ years of experience in food, supplement, or related industry.
• Team leadership experience.
• Familiarity with FDA and GFSI schemes (e.g., SQF, BRC).
• PCQI certification focused on Quality and Food Safety for Supply Chain.
• Ability to lift 50 lbs.; required to stand, walk, sit, and reach.
• Experience operating in an FDA-regulated environment, ideally food or dietary supplement.
• Ability to assess and mitigate food safety, regulatory, and cost risks.
• Effective project management skills with the ability to prioritize and meet deadlines.
• Experience executing CAPA and customer complaint systems.
• Demonstrated ability to understand and organize technical data for communications and analysis.