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Daniel Sutton

Qa Specialist Iii @Gilead Sciences

Riverside, CA, US
MOBILE NUMBERS
+16•••••••15

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WORK HISTORY

Mar 2024 — Present

Qa Specialist Iii @Gilead Sciences

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

2009 — 2013

University of California, Riverside

Bachelor of Science (B.S.), Biochemistry

2005 — 2009

Western Christian High School

High School

SKILLS

Data AnalysisInformation MappingTechnical WritingOral & Written Communication SkillsTeachingScientific PresentationResearchBiochemistryLeadershipKaizenScientific AnalysisGel ElectrophoresisGood Documentation Practices (Gdp)Pharmaceutical Manufacturing TrainingStandard Operating Procedure (Sop) WritingCgmp ManufacturingChange Control DocumentationQuality SystemsProject Management6 SigmaPublic SpeakingMicrosoft ExcelCollaborative Problem SolvingLaboratoryLean ManufacturingLaboratory SkillsRoot Cause AnalysisCell CultureEvent InvestigationMicrosoft Word

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.

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