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Karen Stone Location
Raritan, NJ, US
Karen Stone Work
2018 -now Director of Bioresearch Regulatory Compliance, Johnson and Johnson @
2001 -now Quality Assurance and Compliance Program Manager @
1999 -2001 Quality Assurance and Compliance @
1994 -1999 Quality Assurance and Compliance @
1994 -1995 Operations and Engineering @
Karen Stone Education
Rutgers University
Mini MBA (BioPharma Innovation)
2012-2012
Kean University
BS (Biology)
1990-1995
Karen Stone Skills
21 CFR Part 11
GCP
FDA
Sop
CAPA
GMP
Quality Auditing
Internal Audit
External Audit
IT Audit
Design Control
Pharmaceutical Industry
Medical Devices
Diagnostic
Medical Diagnostics
Research
Manufacturing
Lean Manufacturing
Contract Manufacturing
Manufacturing Operations
Regulatory Submissions
ISO 13485
Validation
Change Control
V&V
Computer System Validation
Regulatory Affairs
Regulatory Requirements
Clinical Trials
GLP
Quality System
Clinical Development
Biopharmaceuticals
Karen Stone Summary
Karen Stone, based in Raritan, NJ, US, is currently a Director of Bioresearch Regulatory Compliance, Johnson and Johnson at The Janssen Pharmaceutical Companies of Johnson & Johnson. Karen Stone brings experience from previous roles at The Janssen Pharmaceutical Companies of Johnson & Johnson, Ortho Clinical Diagnostics and Cordis. Karen Stone holds a 2012 - 2012 Mini MBA in BioPharma Innovation @ Rutgers University. With a robust skill set that includes 21 CFR Part 11, GCP, FDA, Sop, CAPA and more. Karen Stone has 2 emails and 2 mobile phone numbers on RocketReach.
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