QA Specialist II - Operations
Kyowa Kirin, Inc.- U.S.Sanford, North Carolina, United States
Posted April 13, 2026
80960 - 98940 USD
Full Time
About the Company
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.
Job Description
The Quality Assurance Specialist Operations II plays a pivotal role in the launch and ongoing operations of the Quality Assurance organization at Kyowa Kirin's new monoclonal antibody drug substance manufacturing facility in Sanford, NC. This role offers a unique opportunity to shape a culture of quality from the ground up while contributing to the delivery of life-changing therapies.
Requirements
- Apply advanced Quality Assurance expertise across GxP operations to support compliant manufacturing and ensure production goals are met.
- Perform as Shop Floor QA / Manufacturing QA with presence on the manufacturing floor; able to stand for 3 or more hours.
- Independently execute batch record review and approval, participate in Gemba walks, coordinate alarm responses, and conduct logbook audits to uphold operational integrity and regulatory compliance.
Benefits
- 401K with company matching
- Annual Bonus Program
- Generous PTO and Holiday Schedule
- Healthcare Benefits
- HSA & FSA Programs
- Well-Being and Work/Life Programs
- Long-Term Incentive Program
- Life & Disability Insurance
- Concierge Service
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
