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Gordon E Location
Toledo, OH, US
Gordon E Work
2019 -now Senior Project Manager and Technical Specialist @
2021 -now Chairperson ISO and TC 209 - Cleanrooms and Controlled Environments @
2019 -2019 President @ GEM Consulting
2017 -2018 QE Group Lead @
2016 -2017 Regulatory Affairs Manager @
2013 -2016 Senior Technical Specialist @
2011 -2012 Director of Microbial Assays and Specialized Studies @
2008 -2011 Director of Microbiology Operations @
2004 -2008 QC and Validation Manager @
2001 -2004 IDs and Packaging Section Leader @
1995 -2004 Study Director @
1995 -2001 Bioburden Section Leader @
1994 -1995 Associate Study Director @
1990 -1994 Laboratory Technician @
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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