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.

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

Job Description

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 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.

Education/Experience Preferred:

• 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

Physical Requirements/Working Environment:

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time up to 60 minutes.
• Ability to sit for prolonged periods of time up to 60 minutes.
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
• Will work in small and/or enclosed spaces.
• Will work in heights greater than 4 feet.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).