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Wayne Guinn Location
Raritan, NJ, US
Wayne Guinn Work
2021 -now QS Site Compliance Lead and Lead Internal Auditor @
2000 -2018 Senior Business System Analyst @
2000 -2006 Technical Writer Document Management Group at Ortho-Clinical Diagnostics @
1995 -2017 Marketing Consultant at Guinn Consulting @ Guinns Engineering
1974 -1999 Laboratory Manager at Sea View Hospital @ Sea View Hospital, New York Health and Hospitals Corp
Wayne Guinn Education
SUNY Empire State College
MT (ASCP) SH (Medical Technology)
2004-2006
Wayne Guinn Skills
Software Documentation
Medical Devices
Validation
Management
SDLC
Quality Management
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
GMP
21 CFR Part 11
FDA
Change Control
Software Development Life Cycle (SDLC)
ISO 13485
V&V
Quality Assurance
Quality System
CAPA
Cross-functional Team Leadership
Pharmaceutical Industry
Standard Operating Procedure (SOP)
Biotechnology
Six Sigma
U.S. Title 21 CFR Part 11 Regulation
Verification and Validation (V&V)
Wayne Guinn Summary
Wayne Guinn, based in Raritan, NJ, US, is currently a QS Site Compliance Lead and Lead Internal Auditor at Johnson & Johnson. Wayne Guinn brings experience from previous roles at Ortho Clinical Diagnostics, Guinns Engineering and Sea View Hospital, New York Health and Hospitals Corp. Wayne Guinn holds a 2004 - 2006 MT (ASCP) SH in Medical Technology @ SUNY Empire State College. With a robust skill set that includes Software Documentation, Medical Devices, Validation, Management, SDLC and more. Wayne Guinn has 2 emails on RocketReach.
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