Quality Manager


Lowell, MA

Industry: Manufacturing


5 - 7 years

Posted 100 days ago

  by    Susan Fernandez

This job is no longer available.

Our client, a manufacturer of products for the food and pharmaceutical industries, seeks a Quality Manager for a new manufacturing facility. The company, with its roots in R&D testing, has commercialized their manufacturing processes and requires a hands-on, roll up the sleeves Quality Manager that can implement a robust Quality Management System, create SOPs, lead continuous improvement initiatives for Quality, lead GMP audits, etc.

Key responsibilities:

  • Maintain Food Safety Management System compliance to stated FDA regulations per 21 CFR part 111 and 117.
  • Review, edit, and approve quality procedures that are pertinent to the manufacture of safe products.
  • Lead implementation and training of quality related processes and procedures.
  • Responsible for ensuring monthly GMP audits occur and identified issues are resolved.
  • Responsible for Material Review Board (MRB).
  • Perform other duties as determined by Leadership in order to support the business.
  • Responsible for sustaining and contributing to Continuous Improvement strategies and develop best-practices in Quality.

Quality Manager Qualifications:

  • 5+ years of proven Quality Managerexperience in food manufacturing, brewing operations, essential oils manufacturing, or similar regulated manufacturing operations
  • BS in chemistry, food science or similar is preferred
  • Experience with 21 CFR 117, GMP, and FDA audits for nutritional supplements , pharmaceuticals, or food products
  • Extensive knowledge of the requirements needed to satisfy a good Food Safety Management System (HACCP, HARPC, FSMA, Environmental Monitoring, Sanitation, Housekeeping, Allergens, Traceabilifty, Documentation, Training, etc...).
  • Strong verbal, written, analytical and interpersonal skills.
  • Skilled in the use of MS office and capable of generating reports to upper management.
  • Skilled in writing routine SOPS, batch records, flow charts, and other compliance documentation.