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 / Plasma manufacturing / cGMP
Required skills
cGMP compliance, SOP adherence, quality audits, deviation tracking, staff training, donor safety, record keeping, operational observation
Preferred skills
Continuous improvement methodologies (5S, Kaizen), leadership, customer service
Technologies
None 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, host internal/external auditors, maintain qualifications in Medical History, Phlebotomy, and Sample Processing
Seniority
Individual Contributor, operational lead
