Manager, Information Systems @ (December 2010 - September 2013)
Regional Manager @ (June 2005 - October 2010)
CSV Consultant @ (June 2005 - July 2005)
Systems Analyst @ Chiron Corporation (April 2000 - February 2005)
Data Collection Manager @ Jd Franz Research (January 1991 - January 1997)
Technology Manager @
Kevin Loftus Education
University of California - Davis
Bachelor of Arts (English)
1994-1997
Kevin Loftus Skills
21 CFR Part 11
Auditing
Biopharmaceuticals
Biotechnology
Business Analysis
CAPA
Change Control
Change Management
Clinical Trials
Computer System Validation
Cross-functional Team Leadership
Design Control
Deviations
Document Management
Documentation
Drug Development
FDA
GCP
GLP
GMP
GxP
ICH
ISO 13485
Internal Audits
LIMS
Learning Management Systems
Life Sciences
Lifesciences
Management
Medical Devices
Pharmaceutical Industry
Product Quality
Project Management
Quality Assurance
Quality Auditing
Quality Management
Quality System
Regulatory Affairs
Regulatory Compliance
Regulatory Requirements
Regulatory Submissions
SOP
Software Documentation
Software Testing
Technology Transfer
Training
U.S. Title 21 CFR Part 11 Regulation
V&V
Validation
Kevin Loftus Summary
Kevin Loftus, based in Sloughhouse, CA, US, is currently a Associate Director, Quality Assurance at Medicines360. Kevin Loftus brings experience from previous roles at Medicines360, Hana Biosciences, PSC Biotech and Allergan. Kevin Loftus holds a 1994 - 1997 Bachelor of Arts in English @ University of California - Davis. With a robust skill set that includes 21 CFR Part 11, Auditing, Biopharmaceuticals, Biotechnology, Business Analysis and more. Kevin Loftus has 4 emails and 8 mobile phone numbers on RocketReach.
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