QA Specialist II - Operations
The Quality Assurance Specialist II - Operations at Kyowa Kirin North America plays a pivotal role in launching and maintaining the Quality Assurance organization at the new monoclonal antibody drug substance manufacturing facility in Sanford, NC. This position offers a unique opportunity to establish QA systems and processes from the ground up, transitioning into providing technical leadership through GMP readiness, technology transfer, and facility licensure for late clinical and commercial products. The role ensures that all GxP areas within Site Operations comply fully with current GxP standards and applicable global, regional, and site procedures within Kyowa Kirin's Quality Management System.
Key responsibilities include executing core QA activities such as batch record review, Manufacturing Quality Assurance, and oversight of warehouse and incoming quality. The specialist will collaborate cross-functionally to monitor site quality metrics, investigate deviations, and support continuous improvement initiatives. Leveraging the Global Quality Management System, the role ensures alignment with regulatory requirements, including data integrity standards. Participation in regulatory inspections and leadership in quality culture initiatives are also integral to this position.
Candidates should possess a Bachelor's degree in a technical or scientific discipline (e.g., Chemical Engineering, Chemistry, Biology) with a minimum of 2 years of relevant experience in biopharmaceutical manufacturing. Alternatively, an Associate degree with 3 years of relevant experience or a high school diploma with 4 years of relevant experience is acceptable. At least 2 years of experience in a GxP regulated environment focusing on batch record review, batch disposition, Shop Floor QA, Manufacturing Quality Assurance, and/or Incoming Quality Assurance is required. Proficiency in MS Office Suite and experience with Electronic Document Management Systems are also necessary.
The anticipated salary for this position ranges from $40.48 to $49.47 per hour. Kyowa Kirin North America offers a comprehensive benefits package, including 401K with company matching, an annual bonus program, generous PTO and holiday schedules, healthcare benefits, HSA & FSA programs, well-being and work/life programs, life & disability insurance, concierge service, pet insurance, tuition assistance, and employee referral awards.
Kyowa Kirin North America fosters a culture of quality and continuous improvement, emphasizing patient-centric practices and sustainable compliance. Employees are encouraged to take ownership of their tasks, act with initiative, and continuously seek opportunities to learn and grow. The company values collaboration, integrity, and accountability, providing a supportive and inclusive environment for professional development.