Lead Specialist, QA Validation
ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.
The Role
ElevateBio is looking for a Lead Specialist, Quality Assurance Validation (QAV), who will be responsible for managing cGMP compliance from a Quality Assurance perspective on technology transfer process, Engineering manufacturing runs, raw material introduction, method qualification/validation and transfer, and process validation. In addition, this position will support all process and technology transfer risk assessments, technical reports, change controls, discrepancies, deviations and CAPAs related to process validation activities. The candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of goals.
Here’s What You’ll Do
- Act as QA Lead on cross functional Technology Transfer teams, liaison with clients
- Support optimization and development of internal infrastructure for QAV Technology T
