Quality Director

About the role

Oversee the Quality department’s daily functions to ensure processes are utilized in support of manufacturing a high-quality product. Responsible for the development, implementation, and maintenance of Quality Assurance and Control Systems, Regulatory, and other activities.

Responsibilities

• Oversees staff including Quality Assurance Manager, Regulatory & Document Control Specialist, and Lab Technician personnel.
• Oversees routine and non-routine analyses of raw materials, including incoming ingredients, in-process, and finished product.
• Compiles data for documentation of test procedures and maintains testing reporting.
• Maintains facility Equipment calibration system.
• Reviews compliance data and addresses abnormalities.
• Revises and updates Standard Operation Procedures (SOP) as required.
• Formulates and recommends Quality Assurance policies and programs.
• Conducts audits on key material supplier facilities at an established frequency.
• Maintains facility certifications, including but not limited to Organic, Kosher, Halal, HACCP, GMP, and IASC.
• Maintains facility HACCP / Food Safety plan, as well as Food Fraud / Intentional Adulteration and Food Defense plans.
• Responsible for Facility, Quality, and Regulatory-related surveys, including:
  • Information relative to the facility.
  • Information about the freeze dryer/spray dryer, raw material fields, and supplier facilities.
  • Information about the product processes from the point of the fields to finished product.
  • Information regarding Good Manufacturing Practice (GMP), training, and internal auditing.
• Responsible for managing regulatory inspections, including but not limited to the State of Florida, Department of Agriculture, Department of Professional Business & Regulations, and Food & Drug Administration (FDA).
• Responsible for acidified foods FDA filings and completing the Acidified Foods Manufacturing School training.
• Responsible for the Foreign Supplier Verification Program (FSVP).
• Maintains state facility permits as required.
• Maintains customer complaint system including investigation, complaint log, meeting correspondence, corrective action, and investigation report (if applicable).
• Maintains Control Document System including but not limited to:
  • Batch Manufacturing Records.
  • Required computerized data and logs in Operations Department.
  • Product labeling system.
  • Certificates of analysis.
  • Technical bulletins.
  • Product Safety Data Sheets (SDS).
  • Quality and Regulatory (domestic and international) statements.
• Maintains Change Control System to document process and equipment changes.
• Responsible for employee training including but not limited to:
  • Develops training modules and schedules.
  • Conducts scheduled GMP training for employees.
  • Conducts required training according to change control system.
• Maintains Food Safety Manager Certification, or equivalent (like PCQI).
• Maintains current knowledge of changes to applicable regulations and disseminates this information to appropriate individuals within the company.
• Interprets new and existing regulations as they relate to Terry Laboratories products and initiates actions to assure compliance.
• Responsible for Regulatory filing systems, securing documents, and monitoring files for accuracy and completeness.
• Travel as required to audit/inspect vendor facilities.
• Travel, domestically and internationally, as required to support the Sales Team.
• All other duties as assigned.

Requirements

• Bachelor’s Degree in a scientific discipline.
• 5-7 years’ experience in quality control procedures, good manufacturing practice (GMP), and standard operating procedures (SOP) for manufacturing; both in product production and reporting documentation.
• Experience managing a team.
• Computer literacy in Microsoft Office programs and the internet.
• Ability to speak, comprehend, read, and write English.

Benefits

• Medical, dental, vision, life, and disability insurance plans.
• Employee Stock Purchase Program (ESPP).
• 401K program with company match after 12 months of tenure.
• Health Savings Account (HSA) on the HDHP plan.
• SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions.
• Corporate discount savings program and other discounts.
• On-demand training program.
• Access to certification prep and a library of technical and leadership courses/books/seminars after 6+ months of tenure.
• Certification discounts and perks for associations including CompTIA and IIBA.
• Dedicated customer service team for consultants.
• Access to a certified Career Coach.