QA manager

9/19/23

Spring Hill, TN

2140

  • Ensure compliance with established regulations and customer requirements, including GMPs as listed in 21 CFR 111 and 117, and Global Food Safety Initiative (GFSI) scheme;
  • Oversee all quality inspector function in the facility and ensure systems adhere to Quality Food Safety Plan and Quality Manual;
  • Ensure all Food Safety Modernization Act (FSMA) regulations are implemented and maintained and hold a certification as a Preventive Controls Qualified Individual (PCQI);
  • Provide direction, support, and communication to all employees in the facility regarding quality systems, guidelines, and standards compliance;
  • Support product incident problem solving and resolution by Identifying root causes to product quality incidents and using direct staff and collaborating with operations peers to quickly understand the issue;
  • Lead to control product and prevent further incident by implementing effective solutions;
  • Document and track incident reports, corrective actions, and material reviews;
  • Complete final review and approval of product specifications, production batch records, laboratory raw data, labels, and COAs for raw materials and finished products;
  • Ensure finished product formulations and specifications meet label claim;
  • Support internal audits to ensure policies and regulations of FDA (cGMP), TDA, third party certifiers and internal SOPs are followed;
  • Maintain and monitor HACCP/HARPC Program to insure plant sanitation requirements are met;
  • Interface with outside governmental agencies, such as: USDA, FDA, TDA, etc., 3rd party auditors such as: BRC, QAI, OU, etc., and to consumers and customers through investigation and response to complaints;
  • Interface with customers for their audit requirements of our production facilities through continuous monitoring of the Supplier Qualification Program;
  • Maintain records of internal and external deviations, incident reports, corrective/preventative actions and employee training;
  • Monitor and track instrument calibrations;
  • Ensure staff follows all safety procedures;
  • Follow and enforce cGMP guidelines and processes as established in department SOPs;
  • Monitors cGMP and addresses nonconformance;
  • Responsible for releasing quality holds after investigations and testing are complete;
  • Meet goals and objectives as outlined by the Executive Management team;
  • Perform other duties as deemed necessary.

Requirements

  • Bachelor of Science in related discipline preferred;
  • 4+ years’ experience in quality management;
  • Manufacturing quality management experience;
  • Food, cosmetic, or pharmaceutical quality systems experience strongly preferred;
  • Demonstrated leadership and team management skills;
  • Experience in motivating teams and team building;
  • Strong functional and technical skills and background in quality control and in a production environment;
  • Detail oriented and highly organized;
  • Excellent written and oral communication skills;
  • Working knowledge of ERP Systems, LIMS, Microsoft office and general computer concepts;
  • Intermediate math, communication, and problem solving skills;
  • Strong documentation practices and record keeping skills;
  • Ability to follow company processes and procedures;
  • Ability to work without direct supervision.
  • Ability to stand and sit for extended hours;
  • Ability to view a computer screen and type for extended hours;
  • Other physical requirements include occasional squatting, bending, twisting, and bi-lateral hand and wrist movement;
  • Ability to lift up to 25 lbs.;
  • Ability to wear any required PPE;
  • Must be able to occasionally work in an environment that will occasionally contain a powdery substance in the air with or without a respirator;
  • Ability to work around a variation of different smells and aromas;
  • Ability to adjust work schedule as business needs require.

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