QA Specialist II - Operations

Kyowa Kirin North America•Sanford, NC

7h•$40 - $49•Onsite

About The Position

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: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. 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. Key responsibilities include executing core QA activities such as batch record review, Manufacturing Quality Assurance, QA oversight of warehouse, and incoming quality. You will collaborate cross-functionally to monitor site quality metrics, investigate deviations, and support continuous improvement initiatives. Leveraging the Global Quality Management System, you will ensure alignment with regulatory requirements, including data integrity standards. Through active participation in regulatory inspections and leadership in quality culture initiatives, you will help ensure the site operates with excellence, integrity, and accountability. This role reports into the Senior Manager, Quality Assurance

Requirements

Bachelor’s degree in a technical or scientific discipline (e.g., Chemical Engineering, Chemistry, Biology, or related field) preferred, with a minimum of 2 years relevant experience in biopharmaceutical manufacturing also preferred.
Associate degree in a technical field and a minimum of 3 years of relevant experience in biopharmaceutical manufacturing.
High school diploma or equivalent and a minimum 4 years of relevant experience in biopharmaceutical manufacturing.
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.
Results-oriented and able to navigate ambiguity.
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. During construction and commissioning, this position will follow a Monday–Friday day shift schedule. Once the facility is operational, the role will transition to a 2-2-3 day shift (7:00 AM – 7:00 PM). Shift flexibility may be required during production runs.
Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives
Respond promptly, take accountability, and manage tasks efficiently.
Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges.
Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.
Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness.
Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset.
Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.
Contribute positively by recognizing achievements and encouraging a healthy work-life balance.
Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.
Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions.
Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE.
This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.
This position is an on-site and on the manufacturing floor

Nice To Haves

Experience with start-up and operation of biopharmaceutical manufacturing processes is a plus.

Responsibilities

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.
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.

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