QA Manager

 Shift:  Monday - Friday  8:00 am - 5:00 pm

           Hours and Shift may vary from time to time depending upon business requirements

The QA Manager oversees supervision of QA Inspectors and training functions needed to produce, inspect, and test products in the product fulfillment process according to Customer, FDA and other applicable regulatory standards while maintaining employee safety.  

• 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.

• 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.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Note: The above description is not intended to be a comprehensive list of the duties and responsibilities for this position. Prinova reserves the right to change or assign other duties and responsibilities without notice.