Quality Assurance Associate II/III – Donor Eligibility & Suitability

Job description

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel ( CAP-1002 ), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The QA II/III is responsible for performing Quality Assurance oversight and review activities supporting donor eligibility determinations and GMP manufacturing operations for cell therapy products. This role ensures that donor-derived starting materials used for cell therapy manufacturing meet regulatory and internal quality requirements prior to use. The position supports compliance with applicable regulations including 21 CFR 1271, 21 CFR Parts 210/211, and applicable GTP/GMP guidance. QA II/III performs independent review of donor screening documentation, infectious disease testing results, and assoc...