Senior Specialist , Quality Control Tech Transfer & Sample

Position Overview

The Senior Specialist 1, Quality Control Technical Transfer(TT) and Sample Support (SS) provides technical support through effective project management of the QC Sample Plans and QC Specifications in close collaboration with relevant stakeholders, including customers. The Sr Specialist 1, TT/SS interfaces with customers to scope QC Sample Plans and QC Specifications. This role participates in collaborations with cross-functional teams as a representative of QC.

This role supports the timely completion of project milestones and deliverables. This role supports Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines and participates in audits and inspections.

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit:

Responsibilities:

• Collaborates with customers and stakeholders from QC and DS Manufacturing (DSM) to support tech transfers of new customer projects as they relate to QC Sample Plans and DS/DP Specifications
• Participates in updates of controlled GMP documents related to QC Sample Plans and QC Specifications
• Participates in writing and review of change controls of QC Sample Plans for both internal and external changes together with relevant stakeholders, including communication with customers as applicable
• Manages continuous improvement of QC Sample Plans and QC Specifications as needed
• Applies holistic quality system approach through identifying and solving technical and compliance gaps.
• Identifies areas for improvement or remediation related to quality or process and leads through completion and sustainable implementation
• Participates in team compliance activities including writing, changing, and maintaining GMP documents in collaboration with relevant stakeholders and QA
• Ensures compliance with platform, procedures, and global QC vision. Supports management in training compliance with policies and inspections. Supports regulatory requests, audits, and inspections
• Collaborates with the LIMS team and IT department to build DS/DP sample plan and specification functions that meet end-user and customer requirements
• Performs other duties as assigned

Required Skills:

• Excellent verbal and written communication skills and attention to detail
• Ability to lead improvement projects
• Ability to analyze and present data and technical information to others outside of the team
• Ability to solve complex challenges and assist others as needed
• Ability to think strategically, plan, and implement improvements
• Primary contact for clients in the laboratory and eagerness for enhancing customer satisfaction
• Self-driven and dedicated with excellent time management skills
• Flexible with a positive attitude and positive energy; seeks challenges and opportunities
• Ability to work cross-functionally with a diverse team
• Must be flexible to support 24/7 manufacturing facility

Education/Experience

Required:

• Bachelors in Biological Sciences, Engineering, or related science field with 2+ years of relevant experience OR
• Masters in Biological Sciences, Engineering, or related science field with 0 years of relevant experience
• Prior experience with project…