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Position Overview

The Sr. Specialist 2, Global QC Raw Materials GMP Support is responsible for supporting, leading, and participating in activities within the Quality Control Raw Materials department as it relates to Investigations, Deviations, CAPAs and Change Controls. This role supports continuous improvements initiatives, customer contacts, and CLO communications to ensure Global QC Raw Materials (RM) capability of onboarding new materials, updating existing materials, implementing methods and ensuring campaign readiness as applicable.

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, maintains, and improves GMP documents and processes in collaboration with stakeholders and QA

• Supports Global QC RM in training compliance with policies

• Provides technical leadership through effective project management, including improvement projects and technical problem solving with independence

• Authors, reviews, and approves controlled GMP documents related to the Global QC RM area

• Provides risk assessments, regulatory standards/guidance, and validation documents, as required to support QC business and compliance

• Participates in site cross-functional teams as a representative of Global QC RM

• Leads the execution and/or discussions of improvement projects in collaboration with the appropriate groups, across teams to meet business requirements/product disposition metrics

• Evaluates, authors, and reviews change controls and other compliance related documents as applicable

• Ensures compliance with platform, procedures, and global QC RM vision

• Assists and supports completion of projects to milestones

• Applies holistic quality system approach through identifying and solving technical compliance gaps, and areas for improvement related to quality or processes. Oversees completion and sustainable implementation

• Acts as customer POC when applicable. Participates in meetings with the customers on relevant topics e.g. changes, deviations or other issues

• Supports generation of data and status overviews and reports as applicable

• 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

Physical and Work Environment Requirements:

Ability to discern audible cues.

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_** _2025-34284_

**_Category_** _Quality Control_

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