Manager Quality

James Robert Zeller

Atlantic Highlands, NJ ***** 732-***-**** ************@*****.***

Profile

Chemical and Pharmaceutical Quality Professional with diverse experience in leadership roles and proven success in maintaining FDA cGMP compliant Quality systems, while maximizing efficiency and minimizing Cost of Quality. Areas of expertise encompass internal and external auditing, cross functional team leadership, CAPA management. Experience with medical device manufacturing, food processing, and chemical packing. Diligent, ethical, professional with a high degree of integrity and an ability to partner with all levels of an organization.

Professional Experience

Equinox Packaging 11/2011- PRESENT

QA Manager management of all aspects of quality for both OTC and non OTC production in an FDA registered and regulated facility, ensuring compliance with ISO 22716. Created custom database for the management of all quality records and documents.

Liason for FDA audits

Management of microbiological testing for all products

Development and maintenance of SOPs

Assist in the coaching, training, and overall development of staff

CAPA management and disposition of nonconforming materials

Walker Logistics LLC 06/2011 - 11/2011

Quality Manager

Management for all quality functions in a high turnover cosmetics contract packaging environment, handling both OTC and non OTC cosmetics.

Direct supervision of 4 quality control inspectors

Liason with L’Oreal on site quality personel

Real time liason with L’Oreal production planners to resolve quality issues while maintaining delivery goals

Endo Pharmaceuticals 8/2008 – 3/2011

Materials Manager

Direct supervision of all receiving and inventory control personnel. Maintenance of all materials and records for raw materials and components in a cold chain pharmaceutical environment

Keto Foods 9/2003-10/2007

Quality manager

Responsible for all quality functions in a food processing facility. Food Safety and HAACP management.

Emco Chemical Distributors 6/1999 - 9/2003

Quality Manager

Direct supervision of 9 quality inspectors/QA technicians. Co-managed ISO9001 registration of the facility. Developed custom database applications for management and controlled reuse of non conforming materials. Developed custom database application for nonconformance reporting, tracking, and CAPA.

Emco Chemical Distributors Production Area Manager (10/95-06/99)

Sabratek LLC 9/1992-10/1995

Quality Technician

Kessler Ellis Products 3/1988-7/1992

Quality Technician

United Telecontrol Electronics 6/1984-3/1988

Quality Technician

Education

Bachelor of Arts Degree in Natural Science and Mathematics, Thomas Edison State College, Trenton, NJ

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