Senior Manager / Manager / Senior Specialist, Quality Control
Hybrid- Seattle, WA)
Join a growing cell therapy organization that focuses on T-cell therapies for autoimmune and degenerative diseases. The organization is continuing to grow and develop in the Seattle area.
This role is reporting to Quality Assurance and is outside of the lab.
Key responsibilities :
- Manage in-process, release, and stability QC data for raw materials and final products
- Establish timelines, proactively review content, and provide quality and compliance expertise
- Support method transfer, method validation, and analytical data integrity
- Manage and establish timelines for deviations, investigations, CAPAs, and change controls
- Maintain relationships with internal and external partners
Background :
- Experienced in the biotech / pharmaceutical industry - ideally cell-therapy
- Experience in management within QC
- Expert in CAPAs, deviations, change controls, investigations, OOS, and OOT
- Experienced in microbiology, qPCR, flow cytometry, ELISA, and cell-based assays
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