1995 -
1995 Clinical Data Processor, Pharmaceutical R and D @ Centocor
Ken Root Education
Lehigh University 1990
-
1995
Ken Root Skills
FDA
GMP
CAPA
Regulatory Affairs
Validation
Medical Devices
Sop
Pharmaceutical Industry
Biotechnology
V&V
Quality System
21 CFR Part 11
Change Control
GLP
ISO 13485
Computer System Validation
R&D
Aseptic Processing
OpenLab
TrackWise
LabWare LIMS
Quality Assurance
LIMS
Regulatory Submissions
GxP
Quality Auditing
Design Control
HPLC
Quality Management
ISO
ISO 14971
Quality Control
Clinical Trials
Technology Transfer
Clinical Development
Leadership
Business Analysis
Testing
Microsoft Excel
Ken Root Summary
Ken Root, based in Lansdale, PA, US, is currently a Manager, External Supply Integration Quality at The Janssen Pharmaceutical Companies of Johnson & Johnson. Ken Root brings experience from previous roles at Lab Support, Biocoat, Inc., Discovery Laboratories, Inc. and Independent Consultant. Ken Root holds a 1990 - 1995 Lehigh University. With a robust skill set that includes FDA, GMP, CAPA, Regulatory Affairs, Validation and more. Ken Root has 3 emails and 1 mobile phone numbers on RocketReach.
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