Mary Allen
Regulatory Quality Specialist - Product Lunch @D9 Designs Inc
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WORK HISTORY
Regulatory Quality Specialist - Product Lunch @D9 Designs Inc
Develops regulatory-compliant SOP templates for cosmetics and functional beverages in alignment with FDA (21 CFR), EU regulations, and ISO 22716 standards.* Drafts SOPs for Eye Cream and Energy Drink product lines, covering safety/stability testing, INCI labeling, HACCP planning, GMP documentation, and claims substantiation.*Conducts in-depth research on U.S. and EU regulatory frameworks, including FFDCA and DSHEA, to ensure compliance for product development.* Builds and maintains a comprehensive SOP library and regulatory roadmap to support streamlined product launches.*Collaborates with cross-functional teams and utilizes Google Docs, Excel, and Airtable to manage documentation and workflow processes.
EDUCATION
Georgia State University
Master's degree, Biomedical Sciences, General
Ondo State University of Science and Technology, Okitipupa
Bachelor of Technology - BTech, Microbiology and Immunology
ABOUT MARY ALLEN
Graduate Student @ GSU Institute of Biomedical Sciences| Quality Assurance| Continuous Improvement| Pharma| Biotech
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