QA manager

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.