Sr Specialist 2 Global QC Raw Materials GMP Support

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.

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 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 crossfunctional teams as a representative of Global QC RM
Leads the 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:

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

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 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 .