Fujifilm Diosynth Biotechnologies

Position Overview

Sr. Specialist 1, QC Lab Support works under moderate supervision, supporting and participating in QC activities related to investigations, deviations, OOS/OOT, CAPAs, and Change Controls. This role assists in creating and maintaining GMP documents and processes, collaborating with stakeholders and QA. This role contributes to customer contact and CLO communication to support QC capabilities in delivering materials and results. This role helps ensure QC compliance with policies and procedures. This role participates in project management and process improvement initiatives, developing skills in risk assessment. The role requires the ability to work effectively both independently and as part of a team, with growing cross-functional collaboration.

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

• Initiates and authors deviations, CAPA’s, and change controls for the functional groups within QC
• Initiates and supports actions for implementation of solutions, process improvements and CAPAs
• Participates in customer interactions to gain exposure to topics such as changes, deviations, or other issues and gathers data for status overviews and reports deviations upon completion of training and observation
• Reviews and updates stability protocols, sample plans, and specifications related to Drug Substance and Drug Product

updates for controlled GMP documents related to sample plans and specifications

• Coordinates technical projects and performs problem-solving learning to apply analytical and QC improvement methodologies
• Participates in cross-functional team meetings to gain exposure to QC's role in various business processes
• Supports QC laboratories in method troubleshooting efforts by collecting data and assisting team members
• Owns changes in support of QC laboratories through the change control processes, and compliance-related documentation
• Performs continuous improvement activities by developing awareness of quality systems and identifies potential areas for improvement
• Provides recommendations to management on KPI’s as needed to evaluate the changes made
• Assists team members in Contract Laboratory (CLO), communication roles, learning about issues such as OOS's and deviations and compiles data for performance and status reports
• Interacts with clients as needed to support change controls and deviations
• Documents sample receipt, storage, and movement in Labware LIMS and/or internal sample chain of custody forms or logbooks
• Identifies and escalates sample issues to appropriate parties
• Performs other duties, as assigned

Minimum Requirements

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

with 2+ years of relevant experience OR

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

with 0 years of relevant experience

• 1- 3 years relevant experience, experience in a GMP environment

Preferred Requirements

• Experience with KNEAT software
• Experience qualifying analytical instruments

Working & Physical Conditions

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

bility 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 wrists, hands or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Will work in small and/or enclosed spaces.

Will work in heights greater than 4 feet.

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).