Senior Technical Services Specialist @ (November 2019 - April 2021)
Senior Technical Services Specialist @ (March 2017 - October 2019)
Specialist III, Technical Services @ (June 2014 - March 2017)
Validation Engineer III @ (July 2012 - June 2014)
Validation Manager @ (July 2010 - June 2012)
Project Manager, Validation @ (September 2007 - June 2010)
Sr. Validation Specialist @ (September 2006 - September 2007)
Validation Specialist @ (March 2002 - August 2006)
Validation Technician @ (January 2001 - March 2002)
Chemist @ Pharmaceutical Associates Inc. (June 2000 - August 2000)
Tracy Sutton Education
Campbell University
Bachelor of Science (B.S.) (Pharmaceutical Sciences)
1997-2001
Tracy Sutton Skills
21 CFR Part 11
CAPA
Change Control
Change Management
Cleaning Validation
Coaching
Communication
Computer System Validation
Computerized System Validation (CSV)
Constructive Feedback
Continuous Improvement
Corrective and Preventive Action (CAPA)
Document Drafting
Document Management
Document Review
Equipment Qualification
FDA
GAMP
GMP
Good Manufacturing Practice (GMP)
GxP
Leadership
Life Sciences
Organization Skills
Pharmaceutical Industry
Plasma Processing
Presentations
Process Validation
Project Management
Quality System
Regulatory Standards
Requirements Analysis
Resource Management
SOP
Software as a Service (SaaS)
Standard Operating Procedure (SOP)
Team Management
Technology Transfer
Training Programs
U.S. Food and Drug Administration (FDA)
U.S. Title 21 CFR Part 11 Regulation
V&V
Validation
Validation (Drug Manufacture)
Validation Master Plans
Validation Strategy
Tracy Sutton Summary
Tracy Sutton, based in Kings Mountain, NC, US, is currently a QA Validation, Senior Manager at Octapharma Plasma, Inc.. Tracy Sutton brings experience from previous roles at Exela Pharma Sciences LLC, Cosette Pharmaceuticals, Inc. and G&W Laboratories. Tracy Sutton holds a 1997 - 2001 Bachelor of Science (B.S.) in Pharmaceutical Sciences @ Campbell University. With a robust skill set that includes 21 CFR Part 11, CAPA, Change Control, Change Management, Cleaning Validation and more. Tracy Sutton has 2 emails and 3 mobile phone numbers on RocketReach.
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