Specialist I, Quality Control

Kyowa Kirin North America•Sanford, NC

6h•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 Specialist I, Quality Control contributes to the establishment and execution of testing activities within the QC organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC. This position begins in a greenfield environment and progresses through GMP readiness, technology transfer, and facility licensure for Phase III and early commercial products. In this role, you will apply technical knowledge to routine and moderately complex Quality Control tasks, collaborate across functions, and begin demonstrating independent problem-solving. Responsibilities include supporting analytical methods across analytical, bioassay and microbiology, maintaining compliance with current GxP standards, and ensuring alignment with global, regional, and site-specific procedures within Kyowa Kirin’s Quality Management System. This role requires work in a laboratory setting, and is essential to building a reliable, compliant, and science-driven QC function that enables the broader manufacturing and quality strategy. As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts. This role reports into the Senior Manager, Quality Control

Requirements

Bachelor’s degree in biology, cell biology, immunology, biochemistry, biotechnology, or a related life sciences discipline (preferred).
Associate’s degree in biology, biotechnology, or a related life sciences discipline (preferred).
High School Diploma required.
With a Bachelor’s Degree: 0 – 1 year of experience in a Quality Control laboratory supporting GxP-regulated biopharmaceutical manufacturing operations. Relevant internships considered a plus.
With an Associate’s Degree: 1 – 3 years of experience in a Quality Control laboratory supporting GxP-regulated biopharmaceutical manufacturing operations.
With a High School Diploma: 3+ years of direct related experience in a Quality Control laboratory supporting GxP-regulated biopharmaceutical manufacturing operations.
Proficient in MS Office Suite, and Lean Labs or Agile Lean.
Results-oriented and able to navigate ambiguity.
Able to set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives.
Respond promptly, take accountability, manage tasks efficiently. And 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; and contribute positively by recognizing achievements and encouraging a healthy work-life balance.
Proactively collaborate with respect, integrity, and humility, prioritizing collective success over individual gain; demonstrate a resourceful and proactive approach, challenge the status quo, drive innovation, and develop creative solutions.

Nice To Haves

Fluency in Japanese is considered a plus.
Demonstrate a good understanding of Quality Management Systems (QMS), laboratory control subsystems, and applicable regulatory standards; and experience contributing to the start-up of a QC laboratory in a greenfield facility is a plus.
Experience reviewing and contributing to engineering and GxP documentation related to equipment, facilities, and process qualification efforts (e.g., validation protocols, reports, test plans, verification plans, validation master plans, site master file) is a plus.

Responsibilities

Perform routine and moderately complex tasks within the QC scope, contributing to end-to-end lab operations and business processes. Collaborate cross-functionally during early-stage site activities, including implementing equipment, analytical methods, and electronic quality systems (e.g., LIMS, ELN, LES).
Serve as a liaison with Kyowa Kirin Company (Takasaki, Japan) to assist in the qualification and transfer of compendial and non-routine analytical methods in accordance with GxP standards, SOPs, and specifications.
Participate in Global Exchange Program (GEP) requiring travel to Takasaki, Japan, to help develop deeper, more integrated collaboration across global sites and further drive our One Team culture.
Perform sampling, pipetting, system suitability checks, and method execution for quality control testing. Interpret and report data in alignment with ALCOA++ principles and 21 CFR Part 11 requirements.
Contribute to the development and maintenance of site-specific QC procedures within the global Veeva electronic Quality Management System (QMS) to enable operational readiness of the Quality Control Laboratories.
Participate in Site Risk Management activities, documenting risk-based decisions using established methodologies and supporting data. Collaborate with peers to apply risk principles in daily QC operations.
Assist with procurement, installation, and qualification of QC lab equipment and instruments to ensure readiness for GMP operations and production targets; and coordinate and perform sampling and testing activities. Review QC laboratory results for accuracy and completeness under moderate supervision.
Maintain core lab operations, including gowning protocols, personnel and material flow, sample handling, inventory management, lab safety, waste disposal, and cleaning procedures.
Contribute to laboratory reports, including analytical trends, excursions, out-of-specification (OOS) results, and invalid assay documentation.
Collaborate with Operations, Quality Assurance, and Compliance teams to align QC activities with global and regional policies and inspection readiness expectations; and participate in investigations of non-conformances, deviations, and laboratory exceptions. Assist in drafting corrective and preventive actions (CAPAs).
Monitor and report key performance indicators (KPIs) for Site Quality Metrics, including deviations, CAPAs, change controls, OOS, invalid assays, OOT, equipment failures, analytical trends, stability trends, and turnaround times.
Demonstrate ownership of assigned tasks and contribute technical input to build a reliable, compliant, and science-driven QC functions aligned with Kyowa Kirin’s manufacturing and quality strategy; track progress against individual and team goals, communicate updates to the Site Leadership Team, and relevant stakeholders as appropriate.

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