Quality Director

Quality Director

The Quality Director is responsible for the development, implementation, and maintenance of Quality Assurance and Control Systems, Regulatory, and other activities. Will oversee the Quality department's daily functions to ensure processes are utilized in support of manufacturing a high-quality product.

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.
• Maintains testing reporting.
• Maintains facility Equipment calibration system.
• Reviews compliance data and address abnormalities.
• Revise and update 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 but not limited to:
  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 complete the Acidified Foods Manufacturing School training.
• Responsible for the Foreign Supplier Verification Program (FSVP).
• Maintains state facility permits current 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 the following:
  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 the 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 to these regulations.
• 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 internally, as required to support the Sales Team. All other duties as assigned.

Education and

Qualifications:

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.