QA Specialist, DSM Operations (Days 2-2-3 / 0600-1800)
About the role
The QA Specialist, DSM Operations is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration.
Responsibilities
- Provides QA oversight and supports DSM operations in accordance with governing processes and procedures.
- Provides QA support of DSM tasks such as: Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool.
- Real time event triage and implementation of immediate response to identified deviations.
- Area changeover and return to service.
- Real time WO oversight per applicable procedures.
- Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs.
- Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
- Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Biotechnologies sites.
- Works a 12-hour shift on 2-2-3 cadence, 0600-1800.
- Perform other duties, as assigned.
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.
Qualifications
- Strong verbal and written communication skills to partner with different teams and stakeholders.
- Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
- Basic knowledge and application of cGMP compliance and other related regulations.
- Excellent oral and written communications skills and fluency in English.
- Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11 required.
- Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes.
- Team based attitude and ability to build relationships and communicate effectively with others.
- Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment.
- Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
Skills
- Knowledge of cGMP compliance and related regulations.
- Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
- Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software.
- Training and/or familiarity with Quality Risk Management principles.
Benefits
Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki.
Pay
Salary range: $60,000 - $90,000 annually. Exact salary will be determined based on experience and qualifications.
Schedule
Works a 12-hour shift on 2-2-3 cadence, 0600-1800.
Contact
To apply, please visit: https://www.fujifilm.com/us/en/about/region/careers