Sr Specialist 2 Global QC Raw Materials Documentation

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.

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 newlargescale 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 endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll 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 CAPAs as needed

Assess and executes action items of raw material related CCs/VCNs
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:

Bachelors degree in chemistry Biochemistry Microbiology or other relevant scientific discipline with 5 years experience OR
Masters 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:

Indepth 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 viaemail 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.

Fujifilm is committedto 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.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .