Quality Assurance Coordinator

Quality Assurance SpecialistBalchem Corporation develops, manufactures, and markets specialty ingredients that improve and enhance the health and well-being of life on the planet, providing state-of-the-art solutions and the finest quality products for a range of industries worldwide. 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 US and Europe. Founded in 1967, Balchem is a publicly traded company (NASDAQ – "BCPC") with annual revenues over $900 million and a market cap exceeding $4.0 billion. The company consists of three business segments: Human Nutrition & Health; Animal Nutrition & Health; and Specialty Products. Balchem employs over 1,400 people worldwide who are engaged in diverse activities, committed to developing the company into global market leadership positions.Under the direction of the Quality Manager, provide support for quality system activities to assure conformance to established specifications and compliance to FDA 21 CFR 117 regulation and third party certification standards including but not limited to SQF. Work on projects regarding 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. Assist in maintaining quality systems when assigned.Key Responsibilities:Activities Supporting Supply Chain Delivery: Ensuring execution of day-to-day activities supporting supply chain. This may include but is not limited to release, testing, reviewing, troubleshoot and complete verifications/validations/calibrations as required.Compliance & Performance: Ensuring execution of food safety and 3rd party requirements. Responsible for performance and KPIs through auditing, execution, follow-ups. Demonstrates ability to prioritize and bring visibility to non-conformances and key drivers impacting KPI's, assign actions to contain, correct, prevent. Drive root cause analysis on CAPA investigations; ensuring preventive actions are recorded and implemented. Identify operational excellence opportunities and proactively execute on initiatives. Contribute to quality commercialization reviews including specification reviews.Escalated Issue Management – Responsible for identifying and escalating and collaborating on non-conformances. Servicing equipment, Internal Defects and external complaints including root cause and CAPA investigation, completion and effectiveness checks.Optimization & Culture – Supporting operational excellence, continuous improvement activities across the site. Supporting and participating in internal audits. Taking part in engaging and developing cross functional team members.Secondary Responsibilities:Partnership with site leaders and cross functional partners for goal setting, decision-making alignment, and training and development needsSupports Commercialization functions & process as neededCoordinate completion of MSS, Record Review, Verifications, and CalibrationsSupporting execution of audits and delivering system updates.Provide backup support as needed in the department.Effective deployment of quality strategies across site.People:Responsible for development and performance of the site quality laboratory team.Builds strong cross functional relationships and demonstrates ability to effectively influence site strategy & execution.Develops a culture that drives quality improvements and efficiently interfaces with operational excellence processes.Deliver and keep current training programs focused on food safety and quality.Timely escalation and communication of food safety, quality, financial issues.Motivates and builds team strength.Operate as a critical backup if the team is short handed in the labsSystems:Responsible for the effective application of site Product Safety, Product Quality and prerequisite systems. Ensure these systems effectively interface with change control and commercialization processes.Strong ability to root cause issues and prevent recurrence via persistent pursuit of higher hierarchical levels of control than administrative, including but not limited to formula, engineering, and elimination strategies.Responsible for applying an effective internal audit program and that corrective actions are completedCollaborates with R&D, Production, and commercial teams in the development and preparation for production of new Products, Processes, and Equipment to support new product/customer launches. Ensuring the process quantifies the probability of success and clearly communicates the risks and proposed mitigations as an outcome of first-time makes.Interface with operational excellence programs to maximize effectivenessCoordinates with site leaders in preparation for customer visits and external auditsAbility to become site power user for ERP & LIMS systems.Knowledge & Experience:Operated in an FDA regulated environment, ideally food or dietary supplementAssess and mitigate food safety, regulatory, and cost risks.Apply sanitation principles effectively.Effective project manager that knows how to prioritize and meet deadlinesExecution of CAPA and Customer Complaint system.Demonstrated ability to understand and organize technical data for communications and analysisRequirements:Bachelor's degree in a science-related field or relevant experienceTeam Leadership Experience1+ years of experience in food, supplement, or related industry.Ability to lift 50 lbs.; required to stand, walk, sit, and reach.Familiarity with FDAGFSI Scheme (i.e. SQF, BRC)Certification focused on Quality and Food Safety for Supply Chain requirement: PCQIBalchem is committed to a workplace culture that values and promotes diversity, inclusion, equal employment opportunities, and a work environment free of harassment and hostility.