Summary 31 years in quality and engineering, including 15 years in Medical Devices, 9 years in Pharmaceutical, 4 years in Biotechnology and 2 years of Nuclear * Functioned as a Director of Operations for 12 years for Validation Associates, Inc. and Quality System Technologies of Anderson, Inc. Project Manager for 11 years and Sr. Quality Engineer for 5 years and Quality Engineer for 3 years. * Instrumental in leading validation project teams through new construction for 3 Biotech, domestically and 2 Medical Device PAI, internationally * Project Manager for 7 new Medical Device products, from concept to pilot release for saleable product after PAI was approved and 510k submission completed. Moved Manufacturing from Miami to MN for B&L 2001 - 2002 Assisted in the development, automation, and implementation of global CAPA systems, Complaint Management Systems, Audit Tracking Programs, Management Review Processes, Risk Management Systems, PLM Systems, Supplier Quality Management Systems, Process Control Tracking and Trending Systems, Verification and Validation Traceability Systems, Recall Management Programs, Training Traceability Programs, and other QMS systems. * Moved Manufacturing processes from Cincinnati to South Carolina for P&G 1990 - 93 * Transferred manufacturing from GA to Indonesia for Ciba Vision 1994-1994Transferred manufacturing from UK and MN to Mexico for Gyrus 2007 - 2008 * Transferred manufacturing between sites in MN for Zimmer 2008 - 2009 * Set-up 3 Biotech sites Biogen, Covance, and Human Genome Sciences through PAI 1994 - 1997 Developed and executed commissioning protocols (IQ/OQ) and PQ protocols for Air Handlers/HVAC System to include BMS System. Performed system walk downs to verify as-built drawings (IQ), performed execution of temperature mapping for static and dynamic conditions, (OQ). Commissioned Compressors, Clean Gases, Backup Generators and Chiller/Cooling Towers. Develop and executed protocol against URS/FRS (Design Specifications) to qualify a new BMS, MES and PRMS. Validated new and modified USP/WFI/SIP/CIP Water systems. * Set up 2 Medical Device facilities for Ciba Vision and Gyrus through PAI 1994 & 2007 * Remediated FDA 483 observations and diverted the threat of consent decree. * Remediated validation and quality systems observations identified under consent decree by the FDA. * Certified lead Auditor through ISO since 1994 and have performed audits worldwide to identify compliance gaps opportunities for improvements. * Extensive experience managing multiple CAPA Projects, including associated DMAIC and Problem-Solving Skills * Validated facility, utilities, equipment and processes through PAI (Pre-approval Inspections), as well as sustaining existing operations and providing objective evidence of remediation for Pharmaceutical, Medical Device & Biotech companies * Provided guidance and management to a state of validation for manufacturers under a consent decree while training the personnel of the facility to carry on the validation process to enable the facility to remain in a state of control. Air

Highlights:

• Utilities
• BMS
• Quality Assurance
• HVAC
• Protocol
• Pharmaceutical
• Engineering
• Packaging