2012 -2013 Quality Assurance and Compliance Supervisor @
2011 -2012 Quality Systems Analyst @
2010 -2011 Quality Assurance and Compliance Specialist @
2009 -2010 Clinical Services Coordinator II @
2007 -2008 Quality Assurnace and Regulatory Coordinator @
Ashley Dynan Skills
CMC Regulatory Affairs
Compliance Regulations
Quality Management
Continuous Improvement
Due Diligence
Global Regulatory Compliance
Auditing
Team Leadership
Quality Assurance
Organizational Effectiveness
Compliance
Internal Audit
Close Attention to Detail
Team-oriented
Collaborative Work
ISO 13485
FDA GMP
CAPA
Organizational Development
Process Improvement
Time Management
Multi Tasking
Regulatory Affairs
Laboratory
Trackwise
GxP
LIMS
GLP
V&V
Biotechnology
GMP
Medical Devices
Quality System
Standard Operating Procedure (SOP)
U.S. Food and Drug Administration (FDA)
Design Control
ISO 14971
Premarket Approval (PMA)
Regulatory Submissions
Commercialization
cGMP manufacturing
Batch Records
English
Batch Release
New Drug Application (NDA)
NCMR
MDR
ISO Standards
Root Cause Analysis
Failure Mode and Effects Analysis (FMEA)
Project Management
510k
Leadership
CE marking
Certified Quality Auditor (CQA)
Ashley Dynan Summary
Ashley Dynan, based in Denver, CO, US, is currently a Senior Director of Regulatory Affairs at ApiJect. Ashley Dynan brings experience from previous roles at Network Partners, AlloSource® and Bellus Medical . With a robust skill set that includes CMC Regulatory Affairs, Compliance Regulations, Quality Management, Continuous Improvement, Due Diligence and more. Ashley Dynan has 4 emails and 2 mobile phone numbers on RocketReach.
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