Sr Specialist 1 QC Instrumentation

The QC Instrumentation Specialist will work independently to perform routine operations continuous improvement and lifecycle management of the QC analytical instrumentation program. This role will ensure compliance of QC analytical instrumentation with Data Integrity standards in accordance with regulatory guidelines and company policies and procedures. This role will ensure the performance of routine maintenance completing periodic reviews of QC analytical instrumentation to confirm compliance and correct deviations and excursions. The role will also support stakeholders with issues and guidance related to QC analytical instruments. The ability to effectively communicate and function in a fastpaced highly technical environment is essential to success. This role is included in routine oncall and weekend support as needed.

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

• Execute the qualification routine operation maintenance continuous improvement and decommissioning of QC analytical instrumentation.
• Ensure all QC equipment and instruments adhere to regulatory guidelines and site policies.
• Author and review SOPs technical reports user requirements and functional specifications and KNEAT protocols and reports.
• Support data integrity initiatives related to analytical instruments.
• Recommend appropriate user roles and privileges for data integrity (where applicable) write instrument operation instructions and preventative maintenance plans.
• Work with vendors performing maintenance activities on QC analytical instruments.
• Complete periodic reviews of QC instruments and associated instrument control software.
• Identify and followup on excursions and deviations and initiate corrective and preventative actions (CAPAs) related to analytical instruments.
• Support stakeholders including end users with issues and guidance related to QC analytical instruments.
• Work cross functionally with all end users Validation Team Labware Specialists and Quality Assurance.
• Performs other duties as assigned

Minimum Requirements:

• Bachelors degree in Science preferably Chemistry Biochemistry Microbiology Biology or Life Sciences relevant scientific discipline with 3 years of relevant experience OR
• Masters degree in science preferably Chemistry Biochemistry Microbiology Biology or Life Sciences relevant scientific discipline with 1 year of relevant experience
• 1 3 years relevant experience experience in a GMP environment

Preferred Requirements:

• Experience with KNEAT software
• Experience qualifying analytical instruments
• Ability to learn and incorporate lean lab and six sigma six principles into daily work environment.

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

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 .