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Kyowa Kirin, Inc.- U.S. · 3 days 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 focused on delivering novel medicines. The Quality Assurance Operations Specialist III will help establish QA systems at a new manufacturing facility, ensuring compliance with GxP standards and leading quality initiatives to support the delivery of life-changing therapies.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

Execute core QA activities such as batch record review, product disposition, and oversight of warehouse, laboratory, and supplier operations

Collaborate cross-functionally to monitor site quality metrics, investigate deviations, and support continuous improvement initiatives

Leverage the Global Quality Management System in Veeva to ensure alignment with regulatory requirements, including data integrity standards

Participate in regulatory inspections and lead quality culture initiatives to ensure site operates with excellence, integrity, and accountability

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

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 ControlCAPA managementSupplier Quality activitiesMS Office SuiteInterpersonal skillsOrganizational skillsAttention to detailAdaptability

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

Assisted with 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

Executed QA activities related to warehouse operations and incoming material inspections, verifying adherence to cGMP requirements and internal procedures

Reviewed and approved Change Controls, CAPAs, and Deviations, ensuring timely resolution and alignment with quality and regulatory expectations

Led and 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

Experienced using Veeva in the areas of Document Management, Deviation, CAPA, Training, and Change Control

Executed daily QA operations at the manufacturing site while collaborating cross-functionally to drive compliance and continuous improvement

Monitored and reported site quality metrics, including Deviations, CAPAs, OOS, OOT, and product disposition cycle times, to identify trends and improve performance

Contributed to greenfield site startup and biopharmaceutical manufacturing facility operations by establishing compliant QA systems and processes

Executed QA activities related to supplier qualification, including onboarding, monitoring, and recertification, to ensure alignment with quality standards

Collaborated with Quality Control to verify laboratory compliance and maintain data integrity in accordance with cGMP and regulatory requirements

Identified and escalated discrepancies or non-compliant entries within the Quality Management System (Veeva); worked with process owners to resolve issues and ensure records met regulatory and internal standards

Proficient in MS Office Suite

Proficient in using Quality Management Systems for documentation, workflow management, and compliance tracking; experience with Veeva is preferred

Results-oriented and able to navigate ambiguity

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 a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE

Preferred

Advanced degree (e.g., Master's in Regulatory Affairs, Biotechnology, or Quality Systems) preferred

Benefits

401K with company matching

Discretionary Profit Sharing

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

Company

Kyowa Kirin, Inc.- U.S.

Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines.

Founded in 1949

Princeton, New Jersey, US

501-1000 employees

https://kkna.kyowakirin.com/

H1B Sponsorship

Kyowa Kirin, Inc.- U.S. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2025 (1)

2022 (1)

2021 (1)