QA manager
Date Posted
9/19/23
Location
Spring Hill, TN
Position Id
2140
Degree Required
Job Type
Job Description
- 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.