Quality Assurance Associate - Midwest Stem Cell
Core
Ensures compliance with FDA and regulatory authorities for the GMP/GTP facility at the Midwest Stem Cell Therapy Center by managing quality assurance, regulatory documentation, and internal audits.
Role type
Quality Assurance Associate (Regulatory/GMP)
Builds
Compliant cellular therapy manufacturing and testing operations
Domain
Biotechnology / Cellular Therapy / Healthcare
Required skills
GMP compliance, FDA regulations (21 CFR 210/211/1271), SOP development, internal auditing, deviation investigation, batch record review, training management
Preferred skills
GMP environment experience for cellular therapy, knowledge of cGTPs
Technologies
None stated
Responsibilities
Develop and maintain Standard Operating Procedures (SOPs) and quality system documents; Perform internal audit/review systems; Investigate deviations, nonconformances, and CAPAs; Assist with batch record review and document management; Maintain equipment and GMP environment; Train employees and manage training records; Coordinate with other University areas
Seniority
Mid-level, hands-on IC