2025 Summer Internship - Quality Assurance

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 areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes two offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

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 27^th, 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.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Suite 600 Princeton, NJ 08016 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

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