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Simon Connell Location
Kenosha, WI, US
Simon Connell Work
Associate Director Regulatory Labeling @ (November 2019 - Present)
Associate Director Regulatory Labeling @ (July 2019 - November 2023)
Sr. Manager, Labeling Operations @ (August 2014 - June 2019)
Manager, Quality Assurance Labeling @ (February 2009 - August 2014)
Commercial Labeling Operations Manager @ (December 2007 - February 2009)
Label Editor @ (December 2005 - December 2007)
Label Editor @ (January 2003 - January 2005)
Regulatory Documentation Specialist @ (January 2003 - January 2004)
Regulatory Documentation Specialist @ (January 2003 - January 2003)
Recruiter @ Scientific Staffing, Inc/Modis Professional Services (January 1998 - January 1999)
Simon Connell Education
Temple University
Master of Science (Pharmaceutical Quality Assurance and Regulatory Affairs)
2013
University of Iowa
Bachelor of Science (Biology)
1993-1997
West High School
High School Diploma
1988-1992
Simon Connell Skills
GMP
Change Control
Quality Assurance
Pharmaceutical Industry
FDA
Regulatory Affairs
21 CFR Part 11
Validation
Pharmaceutics
CAPA
Sop
Quality System
Document Management
Regulatory Requirements
Software Documentation
GCP
Quality Auditing
Lifesciences
Regulatory Submissions
Pharmaceutical Labeling
Printing
U.S. Title 21 CFR Part 11 Regulation
CRO
Life Sciences
Clinical Development
Standard Operating Procedure (SOP)
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
Editing
Microsoft Excel
Corrective and Preventive Action Capa
Sales
Labeling
Microsoft Office
Marketing
Standard Operating Procedure Sop
u.s. Food and Drug Administration Fda
Standard Operating Procedure
u.s. Food and Drug Administration
Corrective and Preventive Action
Simon Connell Summary
Simon Connell, based in Kenosha, WI, US, is currently a Associate Director Regulatory Labeling at Amgen. Simon Connell brings experience from previous roles at Horizon and Takeda Pharmaceuticals. Simon Connell holds a Master of Science in Pharmaceutical Quality Assurance and Regulatory Affairs @ Temple University. With a robust skill set that includes GMP, Change Control, Quality Assurance, Pharmaceutical Industry, FDA and more. Simon Connell has 2 emails and 2 mobile phone numbers on RocketReach.
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