Chairperson ISO and TC 209 - Cleanrooms and Controlled Environments @ (January 2021 - Present)
President @ GEM Consulting (January 2019 - August 2019)
QE Group Lead @ (September 2017 - December 2018)
Regulatory Affairs Manager @ (March 2016 - September 2017)
Senior Technical Specialist @ (January 2013 - March 2016)
Director of Microbial Assays and Specialized Studies @ (August 2011 - December 2012)
Director of Microbiology Operations @ (March 2008 - August 2011)
QC and Validation Manager @ (January 2004 - February 2008)
IDs and Packaging Section Leader @ (January 2001 - January 2004)
Study Director @ (January 1995 - January 2004)
Bioburden Section Leader @ (January 1995 - January 2001)
Associate Study Director @ (January 1994 - January 1995)
Laboratory Technician @ (August 1990 - January 1994)
Gordon E Education
Brigham Young University
BS (Microbiology, General)
1985-1995
University High School 1982-1985
Gordon E Skills
FDA GMP
Standards Compliance
Biopharmaceuticals
Environmental Monitoring
Global Regulatory Compliance
Client Relations
Microbiologist
Sterilization
Cleanrooms
Contamination Control
Aseptic Processing
Quality Assurance
Quality Control
Medical Devices
Pharmaceutical Industry
Biologics
Aseptic Technique
Standards Development
ISO
USP
IEST
AAMI
ASTM
PDA
AATB
Laboratory Skills
Regulatory Affairs
FDA
GMP
GLP
Cleanroom Design
Cleanroom Operations
Cleaning Validation
Test Validation
Validation
SOP
Change Control
CAPA
Microbiology
Laboratory
Quality System
V&V
Biotechnology
ISO Standards
Corrective and Preventive Action (CAPA)
Verification and Validation (V&V)
U.S. Food and Drug Administration (FDA)
Standard Operating Procedure (SOP)
Good Laboratory Practice (GLP)
Good Manufacturing Practice (GMP)
Gordon E Summary
Gordon E, based in Toledo, OH, US, is currently a Senior Project Manager and Technical Specialist at LexaMed- Microbiology & Analytical Laboratory. Gordon E brings experience from previous roles at ISO - International Organization for Standardization, GEM Consulting and MiMedx. Gordon E holds a 1985 - 1995 BS in Microbiology, General @ Brigham Young University. With a robust skill set that includes FDA GMP, Standards Compliance, Biopharmaceuticals, Environmental Monitoring, Global Regulatory Compliance and more. Gordon E has 2 emails and 7 mobile phone numbers on RocketReach.
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