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Kyowa Kirin, Inc.- U.S. · 18 hours ago

Specialist III, Quality Assurance Operations

Sanford, NC

Full-time

Onsite

Mid Level

$106K/yr - $139K/yr

3+ years exp

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. The Quality Assurance Operations Specialist III will play a pivotal role in establishing QA systems and processes at a new monoclonal antibody drug substance manufacturing facility, ensuring compliance with GxP standards and contributing to the delivery of life-changing therapies.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

Apply advanced Quality Assurance expertise across GxP operations to support compliant manufacturing and ensure production goals are met

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

Participate in batch disposition and support final product release by verifying documentation and quality standards to enable timely and compliant delivery

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

Maintain site Quality Management System procedures within Veeva, leveraging the global QMS structure to ensure consistency and regulatory alignment

Champion a culture of quality in all GxP areas within the Site Operations by providing subject matter expertise focused on patient-centric practices, sustainable compliance, and inspection readiness

Participate in regulatory inspections by demonstrating site compliance and contributing to Quality Assurance activities

Develop, monitor, and communicate progress against goals across functions, to the Site Leadership Team, and to key stakeholders to ensure alignment and accountability

Ensure compliance with current regulatory requirements for Data Integrity (ALCOA+) as applicable to paper and electronic records, including 21 CFR Part 11

Qualification

Quality Assurance expertiseGxP complianceVeeva experienceCGMP standardsBatch record reviewChange Control managementCAPA managementSupplier Quality activitiesMS Office SuiteInterpersonal skillsOrganizational skillsAttention to detailAdaptabilityTeam collaboration

Required

Bachelor's degree in Life Sciences, Chemical Engineering, Pharmaceutical Sciences, Quality Assurance, or a related discipline required

3–5 years of experience in Quality Assurance within biopharmaceutical manufacturing, executing technical and compliance activities across GMP QA functions including Document Control, Training, Inspections, Batch Disposition, Shop Floor QA, Laboratory QA, Vendor Qualification, and Incoming Quality Assurance