Backed by 500 Global.
About the role
The QA Specialist, 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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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
More about this role
This positions supports a 2/2/3 schedule from 6am-6pm.
The QA Specialist, 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. The QA Specialist, Operations ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.
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. Ready to shape the future of medicine?...
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