Senior Specialist 2, Quality Control Technical Transfer and Sample Support

Fujifilm•Holly Springs, NC

3d•Onsite

About The Position

The Sr. Specialist 2, QC Program Management 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 2, TT/SS interfaces with customers to scope QC Sample Plans and QC Specifications. This role participates in and leads collaborations with cross-functional teams as a representative of QC. This role supports the timely completion of project milestones and deliverables. This role supports GMP compliant laboratory operations in accordance with regulatory guidelines and participates in audits and inspections. Company Overview 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 attention to detail. Leads improvement projects.
Excellent verbal and written communication skills. Ability to analyze and present data and technical information to others outside of the team.
Ability to develop and assign tasks develop structured plans.
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 zeal for enhancing customer satisfaction.
Self-driven, dedicated, and systematic and can plan your day and lead planning for others in a structured way.
Flexible, has a positive attitude, positive energy and seeks challenges and opportunities and interested in developing yourself and the team.
Ability to work cross-functionally with a diverse team and represent the department.
Initiator, motivator, mentor for entire team
Bachelors in Biological Sciences, Engineering, or related science field with 5+ years of relevant experience OR
Masters in Biological Sciences, Engineering, or related science field with 3+ years of relevant experience
Prior experience of project management experience preferably 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

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 leading 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.
Authors, reviews, and leads updates of controlled GMP documents related to QC Sample Plans and QC Specifications.
Leads, authors, and reviews change controls of QC Sample Plans for both internal and external changes together with relevant stakeholders, including communication with customers as applicable.
Manages and directs the continuous improvement of QC Sample Plans and QC Specifications.
Applies holistic quality system approach through identifying and solving technical and compliance gaps and areas for improvement or remediation related to quality or process and leads through completion and sustainable implementation.
Leads and 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.
Provides guidance and feedback for QC personnel development.
Performs other duties, as assigned