The QA Specialist, Operations is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes for 12-hour overnight shift. This role collaborates within the DSM Quality team as well as with other cross-functional 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 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.

What You'll Do

• Under the direction of Supervisor, provides QA oversight on the 12-hour 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 exception-based 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
• 1-3 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 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.

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.

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).