QA Specialist II - Operations

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 Technical Skills, Knowledge, and Experience • 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. Individual contributor, with responsibility to lead or work with cross-functional project teams. Education • 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. • Experience with start-up and operation of biopharmaceutical manufacturing processes is a plus. Experience • 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. Technical Skills • Proficient in MS Office Suite. • Proficient in using an Electronic Document Management System for documentation, workflow management, and compliance tracking. Non-Technical Skills • 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. Reasonable accommodation will be provided as required by law. 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 The anticipated salary for this position will be $40.48 per/hr to $49.47 per/hr. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: 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 The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected] . Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [email protected] . Recruitment & Staffing Agencies Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-JC1

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