Quality Assurance Manager

3 weeks ago

Ogden, Utah, United States Balchem Full time
Job Title: Quality Manager

Job Summary:

The Quality Manager is responsible for ensuring the food safety, quality, and efficiency of products manufactured at the site. This individual oversees all quality functions and is responsible for the QC testing and product release. Key responsibilities include inspecting raw materials and finished products to ensure conformance to approved specifications.

Key Responsibilities:
  • Review, revise, and update site SOPs to ensure compliance with Corporate SOPs and the Corporate Quality Manual.
  • Oversee and manage the inspection and disposition of incoming raw materials.
  • Enter and complete CAPAs in D365.
  • Manage customer complaints in D365.
  • Oversee and manage the inspection and disposition of finished products, including filing and archiving inspection records and supplier CoAs.
  • Conduct laboratory analytical tests accurately and in compliance with site procedures.
  • Prepare and ship samples for 3rd party testing.
  • Review batch records and testing results.
  • Release product in the ERP system.
  • Maintain calibration and preventative maintenance programs for instruments.
  • Perform and document OOS investigations as required.
  • Troubleshoot and determine the root cause of quality problems in production.
  • Use risk-based and statistical tools to improve product consistency.
  • Review and approve proposed changes under a Change Protocol.
  • Act as the Food Safety team leader for the facility, maintaining and updating the plan as required.
  • Complete KPI and driver analysis and drive the Continuous Improvement Program.
  • Review and revise best-in-class practices for the food safety plan.
  • Work with R&D on new product development.
  • Work with R&D to support scale-up and hold studies, as well as shelf life studies.
  • Work with the Regulatory Affairs team on registrations.
  • In coordination with corporate document control, maintain, revise, approve, and archive master documents and controlled copies at the site.
  • Maintain product specification sheets for site products that define routine and non-routine test protocols.
  • Ensure that controlled documents (including labels, specifications, new test methods, and technical data sheets) and the ERP system are updated and aligned as required.
  • Work with the plant manager to improve production, product quality, and plant efficiency.
  • Work with plant manager and engineering on capex required for the site.
  • Participate in supplier qualification and supplier audits.
  • Conduct Corporate Internal Audits.
  • Perform regulatory requirements activities of site preventive controls qualified individual (PCQI).
  • Work with cross-functional site and corporate teams to ensure production is operating in accordance with current regulatory requirements - both domestic (21 CFR 217 and 21 CFR 111) and international.
  • Conduct site Internal Audits against applicable CFRs and internal/external requirements, issue reports/responses, and manage corrective actions.
  • Maintain 3rd party certifications (e.g., SQF, DS, Halal, Kosher).
  • Maintain awareness of current global events affecting food & feed quality.
  • On an annual basis, verify and validate prerequisite programs.
  • Lead Regulatory Inspections from the FDA, USDA, etc.
  • Host and document customer quality audits; provide information/corrective actions to customers as needed.
  • Manage training programs.
  • Address customer complaints, technical questions, and surveys while protecting proprietary information.
  • Notify customers of significant changes and any non-conformances that could affect product performance.
  • Assist the site plant manager to advance and promote the safety culture of the site, including the safety training of employees.
  • Manage the site chemical hygiene program.
  • Manage the pest management program.

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