Quality Lead Technician
Core
Ensures source plasma manufacturing consistency and compliance with cGMP regulations at a plasma center.
Role type
Quality Lead Technician (plasma manufacturing)
Builds
Source plasma products for patients with rare diseases
Domain
Healthcare / Biopharmaceuticals / Plasma Collection
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, SOP adherence, quality assurance auditing, deviation tracking, staff training, operational record review, donor suitability assessment, plasma collection and processing, phlebotomy, medical history management, continuous improvement (5S, Kaizen), physical stamina for production environment
Preferred skills
Associate or Bachelor's degree, experience in regulated industry
Technologies
None explicitly stated
Responsibilities
Review operational records for cGMP compliance; track and report deviations; conduct monthly quality assurance audits; ensure SOPs are current and followed; train staff on donor center procedures; maintain qualifications in Medical History, Phlebotomy, and Sample Processing areas
Seniority
Mid-level, hands-on IC