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Position Overview

The Sr. Specialist 2, Global QC Raw Materials (Documentation) is responsible for, but not limited to, implementing new raw materials, including specification authoring, requesting LIMS builds, and assessing changes. This role participates in planning and tracking QC readiness for clinical and commercial manufacturing, and ensures all documentation is in accordance with Good Manufacturing Practices (GMP) and that all reported results are accurate. The Sr. Specialist 2, Global QC Raw Materials onboards new materials in line with Fujifilm Diosynth Biotechnologies (FDB) and customer expectations. This role authors events, deviations, and CAPAs related to new materials, specifications, and other tech transfer activities.

Company Overview

FUJIFILM Diosynth 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

What You'll Do

• Creates specifications for new raw materials and updates existing specifications in line with the specification justifications or agreements with customers

• Provides assessments and QC RM requirements, and executes action items for change controls for the onboarding of materials based on vendor documentation

• Coordinates and drives investigations for deviations and CAPA's, as needed

• Assess and executes action items of raw material related CC's/VCN's

• Authors, initiates, and assesses change controls to handle internal and external changes to specifications

• Plans and tracks QC RM activities to support campaign readiness using smartsheets

• Supports existing customers on RM related topics (e.g. documentation requests for regulatory filings)

• Participates in raw material life cycle management (new material assessment, specification establishment, maintenance of specifications, etc.)

• Reviews work related to specifications and testing strategy documents

• Partners with LIMS team for the creation of LIMS builds for new materials and updates of existing builds for existing materials

• Participates in cross functional, collaborative, and project team assignments

• Performs other duties, as assigned

Minimum Requirements:

• Bachelor’s degree in chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 5+ years’ experience OR

• Master’s degree in chemistry, Biochemistry, Microbiology or other

relevant scientific discipline with 3+ years’ experience OR

• PhD with 1+ years of applicable industry experience

• 4+ years’ experience in a GMP environment

Preferred Requirements:

• In-depth knowledge of Raw Material methodology as it pertains to cGMP

• Experience with Trackwise

Physical and Work Environment Requirements:

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Ability to stand for prolonged periods of time up to 240 minutes.

Ability to sit for prolonged periods of time up to 240 minutes.

Ability to conduct activities using repetitive motions that include wrists, 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 warm/cold environments (5 C)

Will work in small and/or enclosed spaces.

_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._

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]).

**Job Locations** _US-NC-Holly Springs_

**Posted Date** _1 month ago_ _(4/16/2025 4:24 PM)_

**_Requisition ID_** _2025-34282_

**_Category_** _Quality Control_

**_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_