The Quality Assurance Operations Specialist III 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. The 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.
- Execute batch record review and approval, participate in Gemba walks, coordinate alarm responses, and conduct logbook audits to uphold operational integrity and regulatory compliance.
- Support Warehouse and Incoming Quality activities by ensuring materials meet defined specifications and quality requirements.
- Review and approve Change Controls, CAPAs, and Deviations in Veeva to ensure timely execution and alignment with regulatory and quality standards.
- Identify and escalate discrepancies or non-compliant entries within the Quality Management System (Veeva), collaborating with process owners to resolve issues and ensure records meet regulatory and internal standards.
- Lead investigations of non-conformances, deviations, laboratory exceptions, and other cGMP issues; initiate CAPAs and communicate resolution plans to drive effective compliance.
- Conduct Supplier Quality activities including onboarding, monitoring, and recertification to maintain alignment with internal and external quality standards.
- Partner with Quality Control to ensure laboratory operations meet cGMP standards and support consistent, high-quality testing practices.
- Monitor and analyze site quality metrics—including Deviations, CAPAs, Change Controls, OOS, Invalid Assays, OOT, Equipment Failures, EM data trends, Stability Trends, and Product Disposition Cycle-times to identify trends, support continuous improvement, and ensure compliance.
Benefits
- 401K with company matching
- Discretionary Profit Sharing
- Annual Bonus Program (Sales Bonus for Sales Jobs)
- Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
- Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
- HSA & FSA Programs
- Well-Being and Work/Life Programs
- Long-Term Incentive Program (subject to job level and performance)
- Life & Disability Insurance
- Concierge Service
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
