Quality Rep
Core
Monitors systems and activities to ensure source plasma manufacturing complies with cGMP and regulations; authorized to cease operations or stop shipments if safety is compromised.
Role type
Quality Rep (Plasma Collection Center)
Builds
Compliant plasma collection and processing operations
Domain
Healthcare / Biopharmaceuticals / Plasma Services
Required skills
cGMP compliance, regulatory adherence, SOP management, deviation tracking, audit coordination, corrective action evaluation, quality assurance auditing, risk mitigation
Preferred skills
Plasma collection industry experience, FDA-regulated environment knowledge, data analysis, problem-solving
Technologies
Word processing, Excel, databases
Responsibilities
Review operational records for cGMP compliance; track deviations and trends; conduct monthly quality assurance audits; coordinate with center manager on quality concerns; prepare for internal and external audits; evaluate effectiveness of corrective actions.
Seniority
Entry-level to Mid-level, hands-on IC
