Penny Gonzalez Email and Phone Number

• Maintain in-depth knowledge of cGMP and GLP guidelines pertaining to pharmaceutical and diagnostic research manufacturing.• Observe all aspects of radioactive safety that abide by OSHA rules and regulations, including both state and federal regulations.• Ensure all GMP documentation is complete, accurate, and in compliance with 21 CFR 210, 211, and 11.• Write investigation reports and initiating unscheduled work orders. •Observe all aspects of the 5 S Lean way of laboratory and manufacturing operations. Trained and passed all requirements for wearing all respirator equipment.• Work together with Quality Assurance, QC, Microbiology and Materials Management departments.•TEG (Training Expert Group)•Kronos Admin (Time and Attendance)•Primary Trackwise Coordinator for Arlington Heights and South Plainfield sites.•DeCO/MyDoc (Document Management System) SME Perform training and modify documents.•Train the Trainer Certified•Lean: Visual Management, Kanban, and Heijunka•Lean: Kaikaku and Kaizen•Lean: Jidoka and Poka-Yoke•Lean: Six Cigma Green Belt Certified•SAO (Site Authorization Owner) SAP