Specialist, QA Disposition
Core
Supports quality and disposition activities for drug products in a cell therapy facility, ensuring compliance with cGMP regulations and facilitating timely product release.
Role type
Specialist, Quality Assurance Disposition
Builds
Drug product lots for cell therapy
Domain
Biopharmaceuticals / Cell Therapy / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP manufacturing knowledge, batch record review, lot genealogy verification, SOP compliance, electronic system navigation, troubleshooting
Preferred skills
Quality experience, SAP/Veeva/LIMS knowledge, Bachelor's in engineering or life science
Technologies
SAP, Learning Management systems, Document Management systems, Veeva, LIMS/Celabs, Infinity
Responsibilities
Prepare documentation and deliverables for drug product disposition; Verify accuracy of Certificate of Analysis and deviation reports; Review lot genealogy for raw materials and components; Provide shopfloor oversight; Lead troubleshooting sessions with stakeholders; Guide less experienced staff on atypical events
Seniority
Mid-level Specialist