Overview

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

The work we do at FDB 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 FDB 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.

External US

About This Role

The QC Specialist, Instrumentation works under the direction of senior team members to support routine operations, continuous improvement, and lifecycle management of the QC analytical instrumentation program. This role helps ensure compliance with Data Integrity standards, following regulatory

guidelines and company procedures. The Specialist assists with routine maintenance, conducts periodic reviews of QC analytical instruments, and helps

identify and address deviations or issues. The position also involves providing support for on-call and weekend coverage when needed.

What You’ll Do

• Supports the qualification, routine operation, maintenance, and decommissioning of QC analytical instruments.

• Ensures QC equipment and instruments adhere to regulatory guidelines and site policies.

• Assists in drafting and reviewing SOPs, technical reports, user requirements, and maintenance documentation.

• Participates in data integrity initiatives related to analytical instruments.

• Helps recommend appropriate user roles and privileges for data integrity and assists in writing operation instructions and preventativemaintenance plans.

• Coordinates with vendors for maintenance activities on QC instruments.

• Completes routine periodic reviews of QC instruments and their control software.

• Identifies, reports, and follows up on excursions and deviations and assists in corrective and preventative actions (CAPAs).

• Provides support and guidance to stakeholders, including end users, on QC analytical instrumentation.

• Works cross-functionally with all end users as needed.

Minimum Requirements:

• Bachelor’s in relevant scientific discipline, preferably Chemistry,Biochemistry, Microbiology, Biology or Life Sciences

• 0-3 years laboratory experience

• Prior hands-on experience with analytical instrumentation associatedwith the following technologies: UPLC/HPLC, capillaryelectrophoresis/imaged capillary isoelectric focusing, gelelectrophoresis/Western blot, plate readers, qPCR,spectrophotometry, and mass spectrometry

Preferred Requirements:

• GMP laboratory experience

• Experience with Kneat software.

• Experience qualifying analytical instruments

Working Conditions & Physical 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 ascend or descend ladders, scaffolding, ramps, etc

• Ability to stand for prolonged periods of time, up to 60 minutes

• Ability to sit for prolonged periods of time, up to 60 minutes

• Ability to conduct activities using repetitive motions that include writs, 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 using twisting motions

• Will work in small and/or enclosed spaces

• Will work in heights greater than 4 feet

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBNPNC@fujifilm.com _.

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.

Job Locations US-NC-Holly Springs

Posted Date 3 weeks ago (10/22/2024 10:07 AM)

Requisition ID 2024-27115

Category Quality Control

Company (Portal Searching) FUJIFILM Diosynth Biotechnologies