Quality Assurance Associate II/III

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.

We are seeking a Quality Assurance Associate III to join our team. This role is critical in scaling clinical production activities, ensuring compliance with cGMP and regulatory standards. The position involves batch record review, deviation investigations, label issuance, and management of controlled documentation across GLP/GCP/GMP systems. The ideal candidate is detail-oriented, organized, and passionate about driving quality excellence in a fast-paced environment.

• Lead batch record review and disposition for clinical product manufacturing, including label issuance, product packaging, and shipping activities.
• Own deviation investigations and CAPA processes, ensuring timely resolution and compliance; author and approve associated reports.
• Drive change control evaluations and oversee implementation of approved changes.
• Manage controlled documentation within the GxP system (GLP/GCP/GMP), including issuing, tracking, distributing, and archiving records using electronic document management systems.
• Develop and enhance quality management systems, including training programs, SOPs, and standards; provide guidance and mentorship to junior team members.
• Coordinate and maintain controlled records (batch/test records, logbooks, validation documents, labels, reports, forms) for audits, training, equipment calibration, and preventive maintenance.
• Author and approve policies, standards, procedures, and work instructions to ensure compliance and operational excellence.
• Lead supplier quality activities, including qualification, monitoring, and performance reviews.
• Oversee inventory database accuracy, including lot number tracking and timely updates; approve release of incoming materials.
• Represent QA during regulatory inspections and internal audits, preparing and presenting relevant documentation.
• Contribute to regulatory submission activities and ensure readiness for management and material review boards.
• Champion continuous improvement initiatives across QA processes and systems.

• Bachelor’s degree in a scientific discipline (Life Sciences, Engineering, or related field).
• 3–5 years of progressive QA experience in a cGMP-regulated environment.
• Demonstrated expertise in batch record disposition, deviation/CAPA management, and change control oversight.
• Strong knowledge of FDA regulations (21 CFR Parts 210/211), ICH guidelines, and quality systems.
• Ability to author and approve SOPs and quality documentation; experience with electronic document management systems.
• Excellent communication, problem-solving, and decision-making skills.
• Proven ability to work independently, lead initiatives, and mentor junior staff.

Why Capricor?

Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.

Come Work With Us!

At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.

Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.