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Steve Gersten Location
Union, NJ, US
Steve Gersten Work
Lead Tech - Respiratory Product Development @ (May 2014 - Present)
Lead Tech- Clinical Operations @ (June 2006 - May 2014)
Packaging Maintenance Specialist @ (May 2001 - June 2006)
Machine Assembly Supervisor @ (January 1994 - May 2001)
Electrical @ Latendorf conveying (January 1980 - January 1984)
Steve Gersten Education
UCNJ Union College of Union County, NJ
Electro/Mech Technologies
2000-2003
Steve Gersten Skills
21 CFR Part 11
Biopharmaceuticals
Biotechnology
CAPA
Change Control
Clinical Trials
Commissioning
Computer System Validation
Corrective and Preventive Action (CAPA)
Cross-functional Team Leadership
FDA
GAMP
GLP
GMP
Good Manufacturing Practice (GMP)
GxP
Life Sciences
Lifesciences
Manufacturing
Packaging
Process Simulation
Quality Assurance
Quality Control
Quality System
R&D
Regulatory Affairs
Regulatory Requirements
Regulatory Submissions
Research and Development (R&D)
SOP
Standard Operating Procedure (SOP)
Technology Transfer
U.S. Food and Drug Administration (FDA)
U.S. Title 21 CFR Part 11 Regulation
V&V
Validation
Verification and Validation (V&V)
Lean Manufacturing
Computer System
Product Management
Cross Functional Team
Cross Functional Team Leadership
u.s. Food and Drug Administration Fda
Standard Operating Procedure Sop
Research and Development R&d
Engineering
Verification and Validation V&V
Corrective and Preventive Action Capa
Corrective and Preventive Action
Standard Operating Procedure
Research and Development
Verification and Validation
u.s. Food and Drug Administration
Steve Gersten Summary
Steve Gersten, based in Union, NJ, US, is currently a Lead Tech - Respiratory Product Development at Merck. Steve Gersten brings experience from previous roles at Merck, Bobst Group and Latendorf conveying. Steve Gersten holds a 2000 - 2003 Electro/Mech Technologies @ UCNJ Union College of Union County, NJ. With a robust skill set that includes 21 CFR Part 11, Biopharmaceuticals, Biotechnology, CAPA, Change Control and more. Steve Gersten has 1 emails and 1 mobile phone numbers on RocketReach.
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