Backed by 500 Global.
About the role
Join a high-impact Quality Control team where you’ll own the lifecycle of critical analytical instruments that keep life-changing therapies moving. As Sr. Specialist 2, QC Instrumentation, you will lead the routine operation, qualification, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation with minimal supervision—while ensuring data integrity and regulatory compliance at every step.
What they're looking for
- Manage the qualification, routine operation, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation
- Ensure QC equipment and instruments adhere to applicable regulatory guidelines, data integrity expectations, and site policies
- Develop, author, and review SOPs, technical reports, user requirements, functional specifications, and KNEAT protocols and reports
- Lead data integrity initiatives for analytical instruments, including periodic reviews to ensure ongoing compliance
- Recommend user roles and privileges to uphold data integrity, design instrument operating instructions and preventive maintenance plans
- Execute and evaluate periodic reviews of QC instruments and their control software, monitor ongoing performance and drive process improvements
More about this role
Join a high-impact Quality Control team where you’ll own the lifecycle of critical analytical instruments that keep life-changing therapies moving. As Sr. Specialist 2, QC Instrumentation, you will lead the routine operation, qualification, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation with minimal supervision—while ensuring data integrity and regulatory compliance at every step.
You’ll be the go-to expert for instrument performance and reliability, partnering across functions and with external vendors to solve complex problems, drive process improvements, and uphold world-class standards. This role includes periodic on-call and weekend support, as needed.
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...
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