Amber Smith Longest
Senior Quality Manager @Nucleus Biologics
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WORK HISTORY
Senior Quality Manager @Nucleus Biologics
San Diego, CA, US
EDUCATION
Biopharma Institute
Quality Systems Certificate, Quality Management Systems
West Hills High School, San Diego, CA
Diploma, Honors / College Prep
ABOUT AMBER SMITH LONGEST
A customer-centric, outcome-oriented, and motivated professional, I have a solid foundation in ISO 13485 and 21CFR820. My expertise lies in test planning, creation, execution, analysis, and reporting, utilizing analytical tools to guide data-driven strategy planning. I am skilled in developing new products that meet market demands, leading to growth, profitability, efficiency, and member satisfaction. I am passionate about delivering exceptional customer service and proficient in CAPA and NC investigation, including problem statement definition, bracketing, data collection, and analysis. I employ FMEA documentation to prevent adverse impacts and use risk rating based on severity and frequency. I excel at recognizing gaps and producing actionable plans to enhance customer experience.
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