Quality Assurance Coordinator

Balchem • Defiance, OH

15h • Onsite

About The Position

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.

Requirements

• Bachelor’s degree in a science-related field or relevant experience
• Team Leadership Experience
• 1+ years of experience in food, supplement, or related industry.
• Ability to lift 50 lbs.; required to stand, walk, sit, and reach.
• Familiarity with FDA GFSI Scheme (i.e. SQF, BRC)
• Certification focused on Quality and Food Safety for Supply Chain requirement: PCQI

Nice To Haves

• Operated in an FDA regulated environment, ideally food or dietary supplement
• Assess and mitigate food safety, regulatory, and cost risks.
• Apply sanitation principles effectively.
• Effective project manager that knows how to prioritize and meet deadlines.
• Execution of CAPA and Customer Complaint system.
• Demonstrated ability to understand and organize technical data for communications and analysis

Responsibilities

• 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.
• 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.
• 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.
• 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.
• Partnership with site leaders and cross functional partners for goal setting, decision-making alignment, and training and development needs.
• Supports Commercialization functions & process as needed.
• Coordinate completion of MSS, Record Review, Verifications, and Calibrations.
• Supporting execution of audits and delivering system updates.
• Provide backup support as needed in the department.
• Effective deployment of quality strategies across site.
• 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 labs.
• 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 completed.
• Collaborates 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 effectiveness.
• Coordinates with site leaders in preparation for customer visits and external audits.
• Ability to become site power user for ERP & LIMS systems.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level