Keith Fleming Email & Phone Number

Rocky Mount, North Carolina, United States

Greenville, North Carolina, United States

Rensselaer, New York, United States

* Shipped and received 200+ manufacturing and lab equipment units per month that required scheduled calibrations and as needed repairs in an Oracle based Warehouse Management System. Responsible for vendor contact and follow up, required paperwork, calibration certificate review and approval, out of tolerance submissions, data and details for NOEs (Notice of Excursion), and open communications with main warehouse.* Developed and implemented multiple Continuous Improvement projects in order to reduce costs, develop efficiencies, and improve safety.* Escorted and assisted other contractors in the labs and ISO-7 manufacturing facilities

West Point, Pennsylvania

* Led Kaizen Events in the Sterile Supply Department with TPS (Toyota Production System) consultants. Presented results of Kaizen Events at close-out meetings and maintained follow up checklists. Responsible for leading and training team members in Lean Manufacturing and SixSigma principles and tools. Improved processes and eliminated waste by applying 5S, ValueStream Mapping, Standardized Work, and Problem Solving.* Supervised the filling of sterile pharmaceuticals and vaccines in a ISO-5 aseptic environment. Managed 10 to 15 second shift employees plus overtime personnel. Collaborated l with representatives from Environmental Monitoring, Mechanical Services, GMP Compliance, Sterile Supply and Product Release to ensure products were manufactured and released on time.* Assisted the Environmental Monitoring Department with environmental excursions that occurred in the Liquid Sterile Filling Department. Provided information to complete investigations as well as implementing corrective actions. Participated and led Root Cause Analysis teams to determinethe root cause of excursions.* Initiated deviation alerts and championed Atypical Process Reports (APR) by investigating deviation, determining root cause, establishing product impact, and providing corrective actions. Supported other APR champions by providing information needed to research deviations and complete investigations.