Specialist II, Quality Control - Microbiology

Kyowa Kirin North America • Sanford, NC

5d • Onsite

About The Position

The Specialist II, Quality Control Microbiology plays a key role in establishing and executing microbiological 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 evolves through GMP readiness, technology transfer, and facility licensure for Phase III and early commercial products. You apply technical knowledge to routine and moderately complex microbiological tasks, collaborate across functions, and begin demonstrating independent problem-solving. Responsibilities include executing microbiological methods, 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 is essential to building a reliable, compliant, and science-driven QC Microbiology function that supports 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.

Requirements

• Bachelor’s degree in Microbiology, Biotechnology, or a related Life Sciences discipline required.
• Minimum of 2 to 4 years of experience in a Quality Control Microbiology laboratory, providing technical and compliance expertise within GxP-regulated biopharmaceutical manufacturing operations.
• Experience investigating microbial contamination incidents, laboratory non-conformances (e.g., OOS), and interpreting data within the framework of Quality Management Systems (QMS), laboratory controls, and applicable regulatory standards.
• Proficient in MS Office Suite, and Lean Labs or Agile Lean.

Nice To Haves

• Master’s degree or graduate-level studies preferred.
• Experience contributing to the start-up of a QC Microbiology laboratory in a new facility is a plus.
• Familiarity with 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 also preferred.

Responsibilities

• Perform routine and moderately complex microbiological tasks to enable QC operations and contribute to business processes.
• Collaborate cross-functionally during early-stage site activities, including identifying user requirements and prioritizing implementation of equipment, instruments, analytical methods, and electronic quality systems (e.g., LIMS, ELN, LES).
• Execute and assist in the qualification and transfer of compendial and non-routine microbiological methods in accordance with GxP standards, SOPs, and specifications. Techniques include bioburden (TAMC/TYMC), bacterial endotoxins (LAL), growth promotion, microbial identification, and rapid microbiological methods.
• Apply working knowledge of sampling, culturing, microscopy, and aseptic techniques across a variety of sample types (e.g., water, air, gases, raw materials, surfaces, in-process, drug substance, stability, investigations).
• 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 Microbiology Laboratory.
• Participate in Site Risk Management activities, documenting risk-based decisions using compliant methodologies and supporting data. Collaborate with peers to apply risk principles in daily QC operations.
• Implement GxP procedures related to the Environmental and Utility Monitoring Program and Contamination Control Strategy in coordination with cross-functional teams.
• Train and qualify team members in microbiological methods and contamination control practices. Assist in onboarding junior staff and contractors per approved staffing plans.
• Assist with utilities qualification and environmental monitoring performance qualification (EMPQ) to ensure facility readiness and alignment with production goals.
• Review validation and qualification documentation for facility systems, microbiological instruments, and computerized systems to confirm commissioning and operational readiness.
• 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.
• Prepare and contribute to laboratory reports, including microbial trend reports, EM/UM recoveries, excursion reports, OOS, and invalid assay documentation.
• Collaborate with Operations, Quality Assurance, and Compliance teams to align QC Microbiology activities with global and regional policies and inspection readiness expectations.
• Participate in investigations of non-conformances, deviations, and laboratory exceptions. Assist in drafting and implementing 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, EM data trends, stability trends, and product disposition cycle times.
• Demonstrate ownership of assigned tasks and contribute technical input to build a reliable, compliant, and science-driven QC Microbiology function aligned with Kyowa Kirin’s manufacturing and quality strategy.
• Track progress against individual and team goals and communicate updates to the Site Leadership Team and key stakeholders.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level