Kyowa Kirin North America is hiring a
Summer Internship - Quality Assurance

Summary

Join our team as a Quality Assurance intern and gain experience in the pharmaceutical industry, current good manufacturing practices (cGMPs), and the importance of the Quality Assurance department. As a student Intern, you will work closely with the Quality Assurance team on assigned tasks, project work involves Kyowa Kirin preparation and documentation readiness for pre-approval inspection (PAI). This position is a paid, temporary internship eligible to undergraduate students within a commutable distance of Princeton, NJ.

Requirements

• This position requires candidates to have completed at least the first year of a full-time undergraduate program in a health or science related area (e.g., Public Health, Health Policy, Biology etc.)
• Strong written and verbal communication skills
• Interns are required to be able to work from May 27th, 2025 to August 15h, 2025
• The ability to work a hybrid schedule is required
• Candidates are required to live within a commutable distance of Princeton, NJ
• This position requires that candidates be able to work in the United States on a permanent and on-going basis

Responsibilities

• Working closely with the Quality Assurance team on assigned tasks
• Project work involves Kyowa Kirin preparation and documentation readiness for pre-approval inspection (PAI)
• Compile documents to ensure they are readily available for inspection
• Assist with migration of documents from SharePoint sites, (internal and external) to the Electronic Document Management System
• Collaborate with cross-functional team of QA Operations, QA Document Management system, Quality Management Systems, Supply Chain, Logistics and Technical Operations for the creation and development of document binders
• Ensure document metadata is accurate for both newly migrated document as well as existing
• Follow up with cross functional team and obtain necessary documents for project as required
• Support revision, drafts and collaboration of related procedural documents
• Generate and present reports as requested