Tyrone Ortiz Email & Phone Number

Industrial Engineer with over twenty years of experience in the Pharmaceutical, Biopharma and Medical Device industries, including direct managerial/supervisory experience; working in Quality Assurance, Manufacturing and Packaging (Operations), and Supply Chain roles. Broad experience in cGMP environment and in high and low volume production. A committed team player and creative analytical problem solver with demonstrated success in managing new processes to improve quality, efficiency and productivity. Hands-on experience Lean Six Sigma (Kanban, Kaizen, 5S, Just-in-time) and Strategic Planning (Hoshin Kanri).Specialties:  Certified Lean Six Sigma Black Belt  Certified Quality Improvement Associate Deviations or Non-Conformance, CAPA and Change Control Batch Record / DHR and SOP development.  Statistics softwares (Minitab, Statgraphics and QI Macros) ERP systems: JD Edwards, SAP (P34) and SAP-APO (P38) Capacity Analysis and / Planning and Scheduling  Root Cause Analysis (RCA) and Statistical Process Control (SPC) Knowledge using TrackWise, Master Control and Documentum programs. Employee Management, Engagement and Communication (Tier Management System). Production performance (financial and operational) Continuous Improvement - Lean Manufacturing  ISO and cGMP Team Development/Building Strategic Planning (Hoshin Kanri)

Listed skills include Capa, Gmp, Fda, Quality Assurance, and 41 others.