Quality Systems Consultant
Jeff Zumhofe, B.S., is a Quality Systems Consultant at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His expertise focuses on creating and implementing quality systems for compliance with FDA’s cGMP and QSR regulations and international standards, performing audits of quality systems, and training of cGMP/QSR requirements. Jeff has a thirty-eight year career working in FDA regulated industries.
Jeff began his career as a chemist with a veterinary pharmaceutical firm in 1978, having responsibility for analytical test method development and QC testing, microbiology, and implementation of cGMP. He joined 3M Pharmaceuticals in 1985 working in varying capacities ranging from analytical chemist, certified quality compliance auditor, technical support liaison between development and manufacturing, and management roles in validation, quality assurance and global quality systems.
Jeff launched a consulting firm in 2005 and has supported clients in the pharmaceutical, medical device and nutritional supplement industries ranging from start-up firms to multinational corporations in support of new product development and commercial manufacturing within the US, and in Europe, South America, India and Asia/Australia. He has been working with DuVal & Associates for approximately 8 years.
Jeff earned his Bachelor of Science in Biology and Chemistry from Mankato State University. He is currently a member of the Parenteral Drug Association and the International Society of Pharmaceutical Engineers.