Senior Specialist 1, Quality Control Tech Transfer & Sample Support

Fujifilm•Holly Springs, NC

1d•Onsite

About The Position

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: https://www.fujifilm.com/us/en/about/region/careers

Requirements

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
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 management in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO)
1-3 years’ experience in a GMP environment.
Prior experience in leading technical writing initiatives.

Nice To Haves

Masters in Biological Sciences, Engineering, or related science field with 1 year of relevant experience
Experience with Customer Relationship Management
Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting.
Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system)
Prior experience in participating in project improvement management.
LEAN/6S certification

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