Computer Systems Validation Engineer IV @ (December 2021 - August 2026)
Project Manager @ (June 2021 - December 2021)
Software Validation Engineer @ (January 2020 - June 2021)
Computer Validation Engineer @ GSK (August 2016 - January 2020)
Senior Consultant @ Integrity Consulting, a subsidiary of WeiserMazars LLP (April 2018 - September 2019)
Validation Specialist @ (August 2014 - August 2016)
Program Manager @ (October 2012 - August 2014)
Corporate Secretary and Treasurer @ Metal Works Fine Jewelry, Inc. (October 1990 - December 2013)
CSV Consultant, PMP @ (April 2008 - October 2012)
Validation Consultant @ Roche (January 2008 - January 2011)
Validation Analyst and Trainer @ (September 2005 - March 2008)
Quality Analyst @ GSK -- Consultant sent by CTG (January 2006 - January 2007)
Senior Systems Analyst @ Eli Lilly & Company (September 2003 - September 2005)
Technical Writer @ (January 2002 - January 2003)
Writer @ N/A (January 1995 - September 2001)
Instructional Designer and Project Manager @ AgriBusiness Group, Inc (September 1995 - September 2000)
Ellen Gragg Education
Washington University in St. Louis
AB (Bachelor of Arts) (Political Science)
1900-1900
Ellen Gragg Skills
21 CFR Part 11
Budgets
Business Analysis
Business Process Improvement
Change Control
Change Management
Computer System Validation
Consulting
Continuous Improvement
Data Analysis
Editing
Enterprise Software
FDA
GMP
Good Documentation Practices (GDP)
GxP
Instructional Design
Leadership
MS Project
Management
Medical Devices
Microsoft Office
Organization
PMP
Pharmaceutical Industry
Power User of Microsoft Word, Excel, Powerpoint
Process Improvement
Program Management
Project Management
Project Management Office (PMO)
Public Speaking
Quality Assurance
Quality Auditing
Quality System
Requirements Gathering
SDLC
Software Documentation
Strategic Planning
Team Leadership
Testing
Training
Tutoring (online & in person)
U.S. Food and Drug Administration (FDA)
U.S. Title 21 CFR Part 11 Regulation
Validation
Vendor Management
Visio
Webinar Development
Workshop Facilitation
Ellen Gragg Summary
Ellen Gragg, based in Ballwin, MO, US, is currently a Validation Lead at Theoris. Ellen Gragg brings experience from previous roles at Cobalt Content Group (www.cobaltcontent.com), Organogenesis, Olympus Corporation of the Americas and Permobil. Ellen Gragg holds a 1900 - 1900 AB (Bachelor of Arts) in Political Science @ Washington University in St. Louis. With a robust skill set that includes 21 CFR Part 11, Budgets, Business Analysis, Business Process Improvement, Change Control and more. Ellen Gragg has 1 emails on RocketReach.
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