Quality Assurance Manager

2 weeks ago


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

Join Balchem Corporation, a leading developer and manufacturer of specialty ingredients, in the role of Quality Manager. As a key member of our team, you will be responsible for ensuring the highest standards of quality and food safety in our products.

Key Responsibilities:
  • Oversee the quality functions and oversight of the QC testing and product release.
  • Ensure compliance with corporate SOP and corporate quality manual.
  • Manage the inspection and disposition of incoming raw materials and finished products.
  • Enter and complete CAPA 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.
  • 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.
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.
  • 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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