Specialist III, Quality Assurance Operations

Kyowa Kirin North America(3 months ago)

Sanford, NCOnsiteFull TimeMedior$106,300 - $138,800Quality Assurance

About this role

The Quality Assurance Operations Specialist III will help establish and operate the QA function for a new monoclonal antibody drug substance manufacturing facility in Sanford, NC. This individual contributor role focuses on creating QA systems and processes, ensuring GxP compliance, and supporting GMP readiness, technology transfer, and facility licensure for clinical and commercial products. The position emphasizes building a culture of quality, inspection readiness, and cross-functional collaboration to support safe, compliant manufacturing.

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Required Skills

Batch Review
Product Disposition
Warehouse Oversight
Laboratory Oversight
Supplier Quality
Change Control
CAPA Management
Deviation Investigation
Veeva
Data Integrity

+6 more

Qualifications

Bachelor's Degree in Life Sciences, Chemical Engineering, Pharmaceutical Sciences, or Quality Assurance
Master's Degree Preferred

About Kyowa Kirin North America

kyowakirin.com

Kyowa Kirin is a Japanese biopharmaceutical company that develops innovative specialty medicines, with a particular focus on antibody‑based therapies for cancer, kidney disease, and immune‑mediated disorders. The company pursues technology‑driven drug discovery across biologics and small molecules and maintains a broad global network of research, development, and commercial operations. Kyowa Kirin advances a pipeline through internal R&D and strategic partnerships (including biologics and CDMO collaborations) to bring life‑changing treatments to patients. It emphasizes patient‑centred value, scientific expertise, and sustainability in its mission to raise health and well‑being worldwide.