2014 -
2018 Vice President, Global Quality and Compliance @
2010 -
2014 Head- Global Controlled Substance Compliance @
2009 -
2010 Associate Director- Compliance @
1988 -
2009 Manager- Compliance Programs @
Michael Bernstein Education
Rutgers University
M.S. (Radiation Science)
Jefferson Health
BS (Radiologic Technology/Science)
Michael Bernstein Skills
Pharmaceutical Industry
Sop
CAPA
Regulatory Submissions
DEA
Validation
Clinical Development
Six Sigma
GxP
GMP
Microsoft SQL Server
Drug Discovery
Regulatory Requirements
GCP
Compliance Oversight
Health Physics
Compliance Software
Compliance Procedures
Compliance Support
Compliance Investigations
Compliance Training
Data Mining
Drug Distribution
Drug Accountability
controlled substance compliance
Auditing
Import Export
Change Control
Computer System Validation
GLP
Drug Development
R&D
Pharmaceutics
Clinical Trials
Quality Auditing
Technology Transfer
ColdFusion
drug diversion
Quotas
Suspicious Order Monitoring
ARCOS
Enterprise Risk Management
Privacy Compliance
Standard Operating Procedure (SOP)
Corrective and Preventive Action (CAPA)
Team Building
OS X
Help Desk Support
Technical Training
Windows
Sales
Finance
Cross Functional Team Leadership
Windows 7
Requirements Gathering
iOS
Standard Operating Procedure Sop
Security
Integration
Leadership
Good Laboratory Practice Glp
Requirements Analysis
SharePoint
SDLC
Accounting
Networking
Troubleshooting
Software Documentation
Team Leadership
Visual Basic
Microsoft Office
Android
Risk Management
Microsoft Excel
Training
BMC Remedy
Customer Service
MS Project
Teamwork
Project Management
Software Project Management
Hardware
IT Management
Information Technology
Data Analysis
Macintosh Applications
System Administration
Quality Assurance
Strategic Planning
iPhone Support
Molecular Biology
Marketing
Document Management
Technical Support
Project Planning
ITIL
Account Management
Resources
Vendor Management
Process Improvement
Apple Software
Visio
Corrective And Preventive Action Capa
Technical Writing
Compliance
Software Development
System Deployment
Recruiting
Databases
Design Control
Udi
Regulatory Affairs
Pharmacovigilance
It/Is
Consent Decree
Operations Management
Vendor Compliance
u.s. Food and Drug Administration Fda
Corporate Governance
Quality Systems
Commercialization
Standard Operating Procedure
Good Laboratory Practice
Corrective and Preventive Action
u.s. Food and Drug Administration
Michael Bernstein Summary
Michael Bernstein, based in Philadelphia, PA, US, is currently a CTS US Head of Operations at Bionical Emas. Michael Bernstein brings experience from previous roles at Uniphar Clinical, McKesson, Clinigen Clinical Supplies Management and Merck. Michael Bernstein holds a M.S. in Radiation Science @ Rutgers University. With a robust skill set that includes Pharmaceutical Industry, Sop, CAPA, Regulatory Submissions, DEA and more. Michael Bernstein has 2 emails and 2 mobile phone numbers on RocketReach.
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