Quality Assurance Associate II/III – Donor Eligibility & Suitability

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 associated records to ensure donor suitability prior to release of starting materials for manufacturing. Donor eligibility determinations represent a critical quality decision affecting the suitability of donor-derived starting materials for use in cell therapy manufacturing.

 

This role has the authority to perform QA review and approval of donor eligibility and suitability determinations in accordance with approved procedures and regulatory requirements.

In addition, the role supports routine QA Operations activities including batch record review, deviation oversight, change control support, and inspection readiness.

 

The level of this position (QA II or QA III) will be determined based on the candidate’s experience, depth of knowledge, and demonstrated ability to independently perform donor eligibility and suitability determinations with appropriate judgment and minimal oversight.