Quality Manager

2 months ago

Ogden, United States Balchem Full time

POSITION SUMMARY

:

The Quality Manager has overall responsibility for the food safety, quality and efficiency of products manufactured at the site. This individual is responsible for all quality functions and oversight of the QC testing and product release. Responsibilities include oversight of the inspection of raw materials and finished products to determine conformance to approved specifications.

Review, revise, update site SOP. Make sure site SOP are in compliance with Corporate SOP and Corporate Quality Manual. Oversee and manage the inspection and disposition on incoming raw materials. . Enter and complete CAPA in D365. Manage Customer complaints in D365. Oversee and manage the inspection and disposition finished products; file and archive inspections records, including supplier’s CoA Conduct laboratory analytical tests accurately, in compliance with the site’s written procedures, 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; 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. In coordination with corporate document control, maintain, revise, approve and archive, as appropriate, 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 the 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. Performs 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 (21 CFR 217 and 21CFR111) 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 program. 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. 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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