Quality Assurance Intern (Summer 2026)

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

We are currently seeking a student Intern to join our team. As a Quality Assurance intern, you will work closely with the Quality Assurance team as well as the additional areas of the business impacted by the project: Supply Chain Management, Logistics, Product and Project Management, and Technical Operations Management. You will also gain a broad understanding of the pharmaceutical industry, current good manufacturing practices (cGMPs), and the importance of the Quality Assurance department in relation to product quality and our patients.  This position is a paid, temporary internship eligible to undergraduate students within a commutable distance of Princeton, NJ. This role is a hybrid role with some in-office time required.

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).  This will include but not limited to the following day to day activities: 

• 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.

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 26th, 2026 to August 19th, 2026
• 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.

The anticipated hourly rate for this position will be $21.00 to $23.00 per hour.  The actual hourly rate offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.