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Wai So

Quality Assurance Analyst @Tosoh Bioscience, Inc.

Columbus, OH, US
MOBILE NUMBERS
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WORK HISTORY

Jan 2017 — Present

Quality Assurance Analyst @Tosoh Bioscience, Inc.

Grove City, OH, US

Responsible for assisting the Senior Quality Assurance Manager in meeting customer and corporate requirements in support of all Tosoh requirements. • Assisted with all Document Management System functions for procedures, change orders, etc.• Maintained supplier relationships through regular surveys and maintenance of supplier quality files• Performed investigations regarding any nonconformance. Monitored progress of investigation and sent notifications for investigation completion• Managed trending analysis from open CAPAs to nonconformances; customer complaints to personnel training. Includes creating a report for Management Review and Trend Review Board• Assisted with all recall functions• Reviewed any materials used for labeling, advertising, and literature approval documentation

EDUCATION

1990 — 1994

University of Toledo

Pharmacy

1994 — 1998

The Ohio State University

Bachelor’s Degree

1986 — 1990

St. Joseph High School

High School

SKILLS

Change ControlData AnalysisSix SigmaQuality AuditingMicrosoft OfficeR&DCqaQuality ManagementCgmpIsoFdaLean ManufacturingDocumentationMedical DevicesCapaIso 900021 Cfr Part 11Regulatory AffairsQuality SystemQuality SystemsRoot Cause AnalysisValidationTeam BuildingPolicyAuditingLife SciencesRegulatory SubmissionsProblem SolvingWordContinuous ImprovementCompliancePharmaceuticalsProcess ImprovementExcelCosmeticsGlpChange ManagementQuality AssuranceManufacturingTesting

ABOUT WAI SO

Experienced professional with more than 20 years in regulatory affairs and quality…

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