Backed by 500 Global.
About the role
The QA Engineer, Drug Substance Manufacturing (DSM) Operations is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing (DSM) processes through to operational readiness during project phase. This role is responsible for quality assurance oversight of day-to-day activities and resolution or mitigation of issues.
What they're looking for
- Strong verbal and written communication skills to partner with different teams and stakeholders
- Excellent oral and written communications skills and fluency in English
- Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks
- Ability to think critically and have superior problem-solving skills
- High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies
- Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11
More about this role
The QA Engineer, Drug Substance Manufacturing (DSM) Operations is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing (DSM) processes through to operational readiness during project phase. This role is responsible for quality assurance oversight of day-to-day activities and resolution or mitigation of issues.
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? Let’s transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally...
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