SUMMARY Eighteen years experience in Manufacturing or Manufacturing support, including over ten years of supervisory experience. Proven ability to drive production against aggressive schedules while rigorously maintaining safety, quality, and regulatory standards. Expertise in training, documentation, and technical transfer functions. Familiarity with Lean Manufacturing and continuous improvement initiatives. Extensive experience in root cause analysis to recommend justifications, corrective actions, and closure items for process deviations. Close association with Quality arm to ensure best practices and results. Team Leader with a history of effective recruitment, selection, evaluation and discipline of employees. SKILLS/TRAINING *Microsoft Office *21CFR and GMP *Aseptic Technique *Technical Writing *Cleaning Validation *Team Leadership *Training and Mentoring *TrackWise *Audit Preparedness *Quality and Regulatory Compliance *OEE (Overall Equipment Effectiveness) *Process and Equipment Troubleshooting *Routine Equipment Maintenance *OSHA 30-hour certification (May 2015) *L.E.T. trained (Leader Effectiveness Training, June 2014) *HACCP (certified August 2013)

Highlights:

• Documentation
• Good Manufacturing Practices
• Support
• Compliance
• Housekeeping
• Management
• Utilities
• Evaluate
• Kaizen
• Lean Manufacturing