QA Specialist II - Operations

Kyowa Kirin North America•Sanford, NC

10d•Onsite

About The Position

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. Starting in a greenfield environment, you will help establish QA systems and processes, then transition into providing technical leadership through GMP readiness, technology transfer, and facility licensure for late clinical and commercial products. You will ensure that all GxP areas within the Site Operations maintain full compliance with current GxP standards and all applicable global, regional, and site procedures within Kyowa Kirin’s Quality Management System. 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

Minimum of 2 years relevant experience in biopharmaceutical manufacturing (with Bachelor's degree).
Minimum of 3 years of relevant experience in biopharmaceutical manufacturing (with Associate degree).
Minimum 4 years of relevant experience in biopharmaceutical manufacturing (with High school diploma or equivalent).
At least 2 years of experience in a GxP regulated environment, with a focus on batch record review, batch disposition, Shop Floor QA, Manufacturing Quality Assurance, and/or Incoming Quality Assurance.
Performed QA batch disposition and final product release by verifying documentation accuracy and ensuring alignment with regulatory standards.
Reviewed and approved batch records, conducted Gemba walks, responded to alarms, and audited logbooks to maintain operational integrity and ensure compliance.
Reviewed and approved Change Controls, CAPAs, and/or Deviations, ensuring timely resolution and alignment with quality and regulatory expectations.
Performed investigations of non-conformances, deviations, and laboratory exceptions; initiated and followed through on CAPAs to ensure effective resolution.
Participated in regulatory inspections by demonstrating site compliance and executing QA activities aligned with inspection-readiness standards.
Experience using an Electronic Document Management System in the area of Document Management, Deviation, CAPA, Training, and/or Change Control.
Executed daily QA operations at the manufacturing site while collaborating cross-functionally to drive compliance and continuous improvement.
Proficient in MS Office Suite.
Proficient in using an Electronic Document Management System for documentation, workflow management, and compliance tracking.
Ability to stand for 3 or more hours while on the shop floor.
Ability to work a 2-2-3 schedule where each shift is 12 hours in length.
Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE.

Nice To Haves

Bachelor’s degree in a technical or scientific discipline (e.g., Chemical Engineering, Chemistry, Biology, or related field) preferred.
Experience with start-up and operation of biopharmaceutical manufacturing processes is a plus.

Responsibilities

Execute core QA activities such as batch record review, Manufacturing Quality Assurance, QA oversight of warehouse, and incoming quality.
Collaborate cross-functionally to monitor site quality metrics, investigate deviations, and support continuous improvement initiatives.
Leverage the Global Quality Management System to ensure alignment with regulatory requirements, including data integrity standards.
Participate in regulatory inspections and leadership in quality culture initiatives.
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.
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.
Monitor and analyze site quality metrics—including Deviations, CAPAs, Change Controls, Equipment Failures, EM data trends, and Product Disposition Cycle-times to identify trends, support continuous improvement, and ensure compliance.
Review and approve procedures within Veeva, leveraging the global, regional, and local SOPs 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.
Individual contributor, with responsibility to lead or work with cross-functional project teams.

Benefits

401K with company matching
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