Quality Assurance Manager

4 weeks ago

Ogden, Utah, United States Balchem Full time

Job Summary:

The Quality Manager will be responsible for ensuring the food safety and quality of products manufactured at the site. This individual will oversee all quality functions and be responsible for the inspection and disposition of raw materials and finished products.

Key Responsibilities:

  • Review and revise site SOPs to ensure compliance with corporate SOPs and the quality manual.
  • Oversee the inspection and disposition of incoming raw materials and finished products.
  • Enter and complete CAPAs in D365.
  • Manage customer complaints in D365.
  • Conduct laboratory analytical tests accurately and in a timely manner.
  • 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 and maintain and update 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.
  • 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 that production is operating in accordance with current regulatory requirements, both domestic and international.
  • Conduct site internal audits against applicable CFRs and internal/external requirements, issue reports/responses, and manage corrective actions.
  • Maintain 3rd party certifications, such as SQF, DS, Halal, and Kosher.
  • Maintain awareness of current global events affecting food and 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.

Requirements:

  • 4-year degree; preferably in a health science field.
  • 5-7 years of experience in quality; preferably in food or nutritional supplements, pharmaceuticals.
  • Business acumen.
  • Agility and ability to pivot and manage critical issues effectively, along with appropriate and timely escalation of issues.
  • Ability to communicate effectively with all levels of management.
  • In-depth knowledge of FDA regulatory requirements.
  • C skills (MS Office, database management).
  • Analytical and mathematical skills and applications.
  • Strong communication skills (speaking, listening, writing); articulate and quick thinker.
  • Presentation skills.
  • Attention to detail; multi-tasking skills; excellent time management skills.
  • Ability to work independently.
  • Flexibility and adaptability to a rapidly changing, fluid environment.
  • Travel less than 10% or as needed.

Working Conditions:

60% based in an office setting.

40% based in plant/manufacturing setting (occasional exposure to extreme temperatures, noise levels, fumes, airborne particles, machines with moving parts).

Bending; lifting (20-30lbs); kneeling; walking; reaching with arms and hands.

Operate office equipment.

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