Backed by 500 Global.
About the role
The QA Engineer, Drug Substance will serve as a Quality Assurance Specialist responsible for manufacturing quality assurance, working directly with Manufacturing staff during drug substance operations to support real-time decisions on quality requirements and deviations.
What they're looking for
- Understanding of regulations, standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking, cell culture, and protein purification operations
- Collaborative attitude with the willingness to work with global peers and cross-functional teams to build strong partnerships, influence compliant operations, and achieve company and department goals
- Excellent oral and written communications skills and fluency in English
- Attention to detail with strong organizational skills and a commitment to maintaining quality standards while following assignments through to completion
- Problem solving & conflict resolution
- Provide source of knowledge and possess ability to mentor job duties for less experienced team members
More about this role
The QA Engineer, Drug Substance will serve as a Quality Assurance Specialist responsible for manufacturing quality assurance, working directly with Manufacturing staff during drug substance operations to support real-time decisions on quality requirements and deviations. This role fosters strong partnership and knowledge sharing between Manufacturing and Quality teams while providing coaching, guidance, and direction to Manufacturing, Quality Control, Supply Chain, and Facilities & Engineering staff on compliance, quality systems, day-to-day QA oversight, and issue resolution or mitigation. Additionally, this role participates in optimization or improvement initiatives and supports regulatory agency and third-party inspections.
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...
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