Marie Rodriguez
- Role
- Quality Assurance Director, Combination Product Quality at Amgen
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Marie Rodriguez
Subject Matter Expert in Quality Systems ( Investigations, CAPA and CC) and Supplier…
Experience
Quality Assurance Director, Combination Product Quality
Mar 2023 — Present
Skills
- Glp
- Quality Assurance
- Fermentation
- Deviations
- Technology Transfer
- Gxp
- Pharmaceutical Industry
- Biopharmaceuticals
- Chromatography
- 21 Cfr Part 11
- Standard Operating Procedure (Sop)
- Document Management
- Regulatory Submissions
- Sterilization
- U.s. Food and Drug Administration (Fda)
- Sop
- Cell Culture
- U.s. Title 21 Cfr Part 11 Regulation
- Method Transfer
- Computer System Validation
- Fda
- Aseptic Processing
- Gmp
- Quality Control
- Quality System
- Capa
- Operational Excellence
- Life Sciences
- Biotechnology
- Lims
- Cell
- V
- Hplc
- Corrective and Preventive Action (Capa)
- Aseptic Technique
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