John Toporek Email & Phone Number

Rochester, Michigan

Project lead for purchasing I.V. bag Filling & Closing Machine includes responsibility to lead team in writing User Requirement Specification (URS) and verification matrix, project scope, capital cost estimates, reviewing Functional Specifications, Hardware Design Specifications, Software Specifications and building project schedule. Secondary assignment to write URS and verification matrix for a Syringe Filler. These projects include machine handling, operating utilities, machine filling systems, process tracking, machine design and documentation, Factory Acceptance Test, and component specifications and drawings.

Jhp Pharmaceuticals

Nov 2013 – Feb 2014 VTS Consulting – JHP Pharmaceuticals - Rochester, MISr Validation Consultant. Validation consultant to JHP Pharmaceuticals to assist equipment requalification including protocol writing for Installation/Operational and Performance qualification, execution of protocols, analysis and summary reports of sterilizers, freezers, refrig- aerators, and HVAC system equipment to ensure FDA/ISO compliance.

Belleville, Mi

Medical Device/Pharmaceutical Equipment IQ/OQ/PQ V&V. Product Development, Change Control and Quality Improvement

Ann Arbor, Mi

Ann Arbor, Mi

Powertrain Quality engineering analyst specializing in cost, repair and things-gone-wrong warranty improvement/customer satisfaction for Freestar, Monterey, Mustang, Escape and Mariner vehicle lines. High experience in early identification of customer concerns, root cause analysis, problem resolution and communication of action plans to affected engineering and plant management teams.

Bachelor Of Applied Science (Basc), Accounting

Education record