Daniel Sutton
Quality Assurance professional with a passion for data driven process enhancements
- Role
- Qa Specialist Iii at Gilead Sciences
- Location
- Riverside, CA, US
- LinkedIn followers
- 500 followers
About Daniel Sutton
Experienced Quality Assurance Specialist with a background in Biopharmaceutical Manufacturing. Seeks to bring cross functional experience and collaboration to root cause analysis and proactive/continuous improvement.Skilled in risk analysis, technical writing and Six Sigma principles.
Experience
Qa Specialist Iii
Mar 2024 — Present · La Verne, CA, US
Provides QA oversight of the Change Control process for Commercial and Clinical Manufacturing site. Authors Annual Product Quality Report (APQRs) including internal and external data collection and review. Authors and reviews site quality metrics including Quality Management Review and core metrics. Supports Trackwise and Veeva Quality System as Business Administrator. Provides QA approval for Validation documentation including Protocols, Periodic Reviews and Qualifications. Served as shutdown QA oversight assessing and mitigating risk by ensuring compliant implementation of change controls and facility maintenance. Supports external audits in the war room and as an SME to ensure global regulatory requirements.
Education
University of California, Riverside
Bachelor of Science (B.S.), Biochemistry
2009 — 2013
Western Christian High School
High School
2005 — 2009
Skills
- Data Analysis
- Information Mapping
- Technical Writing
- Oral & Written Communication Skills
- Teaching
- Scientific Presentation
- Research
- Biochemistry
- Leadership
- Kaizen
- Scientific Analysis
- Gel Electrophoresis
- Good Documentation Practices (Gdp)
- Pharmaceutical Manufacturing Training
- Standard Operating Procedure (Sop) Writing
- Cgmp Manufacturing
- Change Control Documentation
- Quality Systems
- Project Management
- 6 Sigma
- Public Speaking
- Microsoft Excel
- Collaborative Problem Solving
- Laboratory
- Lean Manufacturing
- Laboratory Skills
- Root Cause Analysis
- Cell Culture
- Event Investigation
- Microsoft Word
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