Sr. Specialist 1, QC Lab Support

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 crossfunctional collaboration.

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

Initiates and authors deviations CAPAs 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 problemsolving learning to apply analytical and QC improvement methodologies
Participates in crossfunctional team meetings to gain exposure to QCs 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 compliancerelated documentation
Performs continuous improvement activities by developing awareness of quality systems and identifies potential areas for improvement
Provides recommendations to management on KPIs as needed to evaluate the changes made
Assists team members in Contract Laboratory (CLO) communication roles learning about issues such as OOSs 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

Bachelors degree in science preferably Chemistry Biochemistry Microbiology Biology or Life Sciences relevant scientific discipline
with 2 years of relevant experience OR
Masters 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 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 ().