Oliver
Student at Cornell University
- Role
- Quality Assurance Intern at Kyowa Kirin, Inc.- U.S.
- Location
- Ithaca, NY, US
- LinkedIn followers
- 500 followers
About Oliver
Hi everyone! My name is Oliver Cai and I am currently a senior at Cornell studying Global…
Experience
Quality Assurance Intern
May 2025 — Present · Princeton, NJ, US
Transferred over 400+ GMP-related documents into Veeva Quality Management System (QMS), including PPQ batch records, master batch records, test methods, and PV files to support regulatory compliance for a new DS manufacturing site- Developed standardized nomenclature/metadata frameworks aligned with Good Documentation Practices- Drafted WIs and SOPs for batch record documentation and QMS upload processes for future transfer- Sourced and consolidated documents from internal/external SharePoint sites, Veeva Change Control, Tech Ops (KKNA), and Japan headquarters (KKC) to ensure complete data capture for U.S. manufacturing site launch- Created flowcharts showcasing DS Process and Media/Nutrients Upstream and Downstream process steps and documents- Organized digital binder systems for key regulatory documents to support internal and external audit processes- Presented internship project findings to QA leadership, demonstrating understanding of regulatory documentation control
Education
Cornell University
Senior
2022 — 2026
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