AMVETS Jobs

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

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

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 (FDBN_PNC@fujifilm.com).

Job Locations US-NC-Holly Springs

Posted Date 5 days ago (4/16/2025 4:24 PM)

Requisition ID 2025-34284

Category Quality Control

Company (Portal Searching) FUJIFILM Diosynth Biotechnologies