Michelle S.
Continuous Improvement is a mindset of passion and curiosity; question the past to drive a future of creative change.”
- Role
- Senior Quality Assurance Specialist at Solvias
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Michelle S.
Dynamic quality leader with a laboratory & research background. Bachelor\'s degree focused in Biology/Genetics from Rutgers, The State University of New Jersey-New Brunswick; Go Knights! I have 20 years of experience in genomics, quality assurance, quality systems, and quality control. Expert skills include systemic harmonization, quality program implementation, training, and monitoring, specializing in continuous improvement strategies, internal/external audit practices, QC and stability testing, genotyping, sequencing, and data analysis. Working knowledge of supply chain management and lean six sigma practices, as well as, international and domestic interpretation & application of FDA, ICH, ISO, EPA, WHO, DEA, OSHA, CLIA, EMA, OECD, GAMP regulations and guidelines as they apply to: GDPR, Data Security/Integrity, Part 11, GLP, GCLP, cGMP, GCP, GTP, GxP, and GDP (Good Distribution Practices) and GDP (Good Documentation Practices)
Experience
Senior Quality Assurance Specialist
Jul 2025 — Present
Education
Rutgers University
Bachelor's degree, Biology/Genetics
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