QA Specialist Operations Night

The QA Specialist Operations is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes for 12hour overnight shift. This role collaborates within the DSM Quality team as well as with other crossfunctional teams. Ensures that applicable DSM systems and processes are operated/maintained as intended with a focus on consistent policy administration QA oversight of activities occurring during the shift and resolution or mitigation of issues occurring during operation.

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

Under the direction of Supervisor provides QA oversight on the 12hour overnight shift and supports DSM operations in accordance with governing processes and procedures
Provides QA support of DSM to include:
a. Batch Record and Solution Lot Record review including exceptionbased oversight using Quality Review Management tool
b. Real time event triage and implementation of immediate response to identified deviations
c. Area changeover and return to service
d. Real time WO oversight per applicable procedures
Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs
Contributes to the development of QA documentation procedures and processes for operational readiness objectives and QA support of
manufacturing operations in cGMP regulated facility
Performs other duties as assigned

Minimum Requirements:

BS/BA in Life Sciences or Engineering or equivalent with 2 years of relevant experience OR
Masters in Life Sciences or Engineering or equivalent with 0 years relevant experience
13 years experience in a GMP environment
Experience in Validation cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility

Preferred Requirements:

2 years of experience in GMP Quality Assurance and/or similar role
Experience and working knowledge of ASTM E2500 Smartsheet Trackwise MasterControl and/or Kneat validation software

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to stand for prolonged periods of time up to 60 minutes.

Ability to sit for prolonged periods of time up to 120 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.

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 .