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Steve Gersten Location
Summit, 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
Manufacturing
Sop
Validation
Commissioning
Change Control
R&D
CAPA
Quality Assurance
FDA
Packaging
21 CFR Part 11
Clinical Trials
Quality System
GLP
V&V
Cross-functional Team Leadership
Biopharmaceuticals
Regulatory Submissions
Regulatory Affairs
Biotechnology
Technology Transfer
Regulatory Requirements
GxP
Quality Control
Process Simulation
Computer System Validation
Lifesciences
GAMP
GMP
Life Sciences
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 Summit, NJ, US, is currently a Lead Tech - Respiratory Product Development at Merck. Steve Gersten brings experience from previous roles at Merck (Formerly Schering Plough), Schering-Plough Pharmaceuticals, Bobst Group and Latendorf conveying. Steve Gersten holds a 2000 - 2003 UCNJ Union College of Union County, NJ. With a robust skill set that includes Manufacturing, Sop, Validation, Commissioning, Change Control and more. Steve Gersten has 1 emails and 1 mobile phone numbers on RocketReach.
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