D'Amore-McKim School of Business at Northeastern University
Regulatory Affairs in Drugs (Biologics and Medical Devices)
2011-2015
Paine College
Bachelor of Science (Chemistry)
1983-1989
Julia Raye Skills
21 CFR Part 11
Analytical Chemistry
Aseptic Processing
Biopharmaceuticals
Biotechnology
CAPA
Change Control
Chromatography
Cleaning Validation
Clinical Trials
Computer System Validation
Cross-functional Team Leadership
Design Control
FDA
FMEA
GCP
GLP
GMP
Gas Chromatography
GxP
HPLC
ISO
ISO 13485
LIMS
Laboratory
Lifesciences
Medical Devices
Pharmaceutical Industry
Pharmaceutics
Process Improvement
Process Simulation
Quality Assurance
Quality Auditing
Quality Control
Quality Management
Quality System
Quality Systems
R&D
Regulatory Affairs
Regulatory Requirements
Regulatory Submissions
Root Cause Analysis
SOP
Six Sigma
Software Documentation
Technology Transfer
V&V
Vaccines
Validation
Julia Raye Summary
Julia Raye, based in Woodbridge, VA, US, is currently a Principal Owner at Raye Regulatory Auditors. Julia Raye brings experience from previous roles at Service Source- contract, ImmunoTek Bio Centers, LLC, Kelly Scientific Resources- contract and Oxford International. Julia Raye holds a 2011 - 2015 Regulatory Affairs in Drugs in Biologics and Medical Devices @ D'Amore-McKim School of Business at Northeastern University. With a robust skill set that includes 21 CFR Part 11, Analytical Chemistry, Aseptic Processing, Biopharmaceuticals, Biotechnology and more. Julia Raye has 2 emails and 3 mobile phone numbers on RocketReach.
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