Stephanie Dumas
Quality Assurance Professional
- Role
- Quality Systems Senior Specialist at Randstad USA
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Stephanie Dumas
Skilled, dedicated, and highly motivated Quality Assurance professional with 20 years experience in a fast paced GMP environment working cross-functionally to support aspects of Quality Assurance including Regulatory, Compliance, and Supplier Management. • Direct experience with, and technical knowledge of, the administration of an electronic document management system (EDMS) in a GxP industry. • Knowledge of US and EU cGMP regulations and guidance. • Direct experience with FDA/EU Pre-approval Inspection preparation and management.• Knowledge of biotech bulk and finished product manufacturing.• Technical Writing and Procedure development. • Experience with Internal Auditing, Management of Quality Agreements, BSE/TSE questionnaires, Annual Product Quality Review, and Site Master File.
Experience
Quality Systems Senior Specialist
Aug 2025 — Present
Education
Salem State University
BS, Geography
1998 — 2004
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