PAT Vitamins

QA, Regulatory Specialist and Technical Support

This position is for an entry/junior level. The specialist oversees QA and technical documents according to FDA and other applicable regulatory standards while maintaining employee safety. This position also provides technical support to the customers.

• Oversee all quality functions in the facility and ensure systems adhere to Quality Master Plan
• Lead product incident problem solving and resolution. Identify causes to product quality issues and prevent further incident by implementing effective solutions.
• Document and track incident reports, corrective actions, and material reviews;
• Evaluating vendor/original manufacturer and updating their technical documents
• Complete final review and approval of product specifications, laboratory raw data, labels, and COAs for raw materials
• Complete internal audits to ensure policies and regulations of FDA (cGMP) and internal SOPs to be followed;
• Interface with outside governmental agencies, such as: USDA, FDA and to customers through investigation and response to complaints;
• Interface with customers for their audit requirements and provide technical support through continuous monitoring of the Supplier Qualification Program;
• Maintain records of internal and external deviations, incident reports, corrective/preventative actions and employee training; Ensure staff follows all safety procedures;
• Technical Support experience on nutritional application a plus
• Bachelor of Science in related discipline or 3-5 years of equivalent experience required
• Food, cosmetic, nutritional, or pharmaceutical quality systems experience strongly preferred;