Quality Rep
Core
Monitors plasma collection center systems and activities to ensure source plasma manufacturing consistently meets cGMP and regulatory standards for product and donor safety.
Role type
Quality Rep (Plasma Collection Center)
Builds
Safe, compliant source plasma products for patients with rare diseases
Domain
Healthcare / Plasma Collection / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, regulatory monitoring, SOP adherence, deviation tracking, audit coordination, corrective action evaluation, data analysis, record keeping
Preferred skills
Plasma collection industry experience, FDA-regulated environment understanding, problem-solving, coaching
Technologies
Word processing, Excel, databases
Responsibilities
Review operational records for cGMP compliance, track deviations and trends, conduct monthly quality assurance audits, coordinate with center management on audits and corrective actions, provide feedback on employee performance and recruitment
Seniority
Entry-level to Mid-level, hands-on operational oversight