Quality Assurance Associate - Midwest Stem Cell
Core
Ensures compliance with FDA and regulatory standards for a GMP/GTP stem cell therapy facility by managing quality assurance, regulatory documentation, and internal audits.
Role type
Quality Assurance Associate (GMP/GTP)
Builds
Compliant cellular therapy products and quality systems
Domain
Biotechnology / Cellular Therapy / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, cGTP knowledge, SOP development, internal auditing, deviation investigation, batch record review, regulatory documentation
Preferred skills
Cellular therapy manufacturing experience, FDA regulation expertise (21 CFR 210/211/1271)
Technologies
GMP systems, batch record software, audit management tools
Responsibilities
Develop and maintain Standard Operating Procedures (SOPs), perform internal audits, investigate deviations and nonconformances, assist with batch record review, maintain equipment and GMP environment, train employees on quality practices
Seniority
Mid-level, hands-on IC