Quality Assurance Operations Associate III, Donor Compliance

About Capricor Therapeutics
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to developing transformative therapies for rare diseases, with a primary focus on Duchenne muscular dystrophy (DMD). We are pioneers in cell therapy and exosome-based technology, leveraging our innovative platforms, including our lead product, deramiocel (CAP-1002), and our proprietary StealthX™ platform, to engineer cutting-edge treatments. Our team is committed to harnessing advanced science and technologies to meet the unmet needs of patients living with DMD and other challenging medical conditions. Join us on our journey as we push the boundaries of medical science and pave the way for a healthier future.

About the Role
We are seeking a meticulous and self-motivated Quality Assurance Operations III to join our Quality Assurance team at our SD1 site in San Diego, US. In this role, you will play an essential role in supporting commercial product launch and routine production by conducting rigorous donor tissue documentation review, batch record review, and product release activities. You will ensure compliance with regulatory standards, including 21 CFR Part 1271 and HCT/P guidelines, while collaborating with cross-functional teams to maintain quality standards and drive process improvements, advancing our mission to transform medicine and improve patients’ lives.

Responsibilities

• Conduct donor tissue record review, batch record review/disposition, and label printing to support commercial product manufacturing.
• Review and disposition donor eligibility records, ensuring compliance with 21 CFR Part 1271 and applicable FDA guidance on human cells, tissues, and cellular & tissue-based products (HCT/Ps).
• Verify donor screening and testing meet regulatory and internal acceptance criteria, escalating non-conformances and driving timely corrective/preventive actions (CAPAs).
• Author, coordinate, and investigate deviations, CAPAs, change controls, and internal audits across cGMP and Good Tissue Practice (cGTP) operations.
• Process and control GxP documentation (creation, routing, issuing, archiving) within an electronic document management system.
• Coordinate, track, and archive controlled records (e.g., batch/test records, logbooks, validation documents, labels, reports, forms) for change controls, deviations, CAPAs, audits, training, equipment calibration, and preventative maintenance.
• Write and review policies, standards, procedures, and work instructions to document quality processes and practices.
• Manage inventory database, ensuring accurate and timely updating of lot numbers and quantities.
• Perform review and release of incoming materials.
• Support cross-training in QA operations for drug product and drug substance disposition across clinical and commercial programs.
• Collaborate with Process Development, Manufacturing, and organ procurement organization (OPO) partners to ensure quality standards in tissue procurement and production.
• Train and mentor junior QA staff (e.g., QA Associate I/II) on regulatory requirements, donor screening, and quality processes.
• Support regulatory and submission activities, including preparing materials for Management Review and Material Review Board meetings.
• Identify compliance gaps and implement corrective actions to drive process improvements.
• Other responsibilities as assigned related to quality assurance and regulatory compliance.

Requirements

• Bachelor’s degree in Life Sciences, Biotechnology, or related field; advanced degree preferred.
• 6–8 years of experience in an FDA-regulated (cGMP/cGTP) environment, preferably in commercial cell therapy.
• Demonstrated knowledge of 21 CFR Part 1271 (donor eligibility, recovery, processing, storage, labeling, distribution) and related regulations/guidance (21 CFR 210/211, FDA HCT/P Donor Eligibility Guidance, cGTP, 21 CFR Part 11).
• Strong grasp of core Quality Operations functions: document control, deviation/CAPA, change control, training, supplier management, and audit readiness.
• Proficiency in Microsoft Word, Excel, Visio, Access, Adobe suite, and database systems.
• Excellent oral and written communication skills, with attention to detail and strong record-keeping abilities.
• Familiarity with quality systems and records management in a cGMP environment.
• Strong problem-solving skills with the ability to coordinate and perform multiple activities.
• Results-oriented with a dedication to compliance and customer service.
• Ability to work independently with strong initiative and follow-through in a fast-paced, cross-functional, and dynamic environment.
• Comfortable with rapidly changing priorities and working in a classified area (ability to gown as required).
• Authorization to work in the United States without the need for sponsorship.

Preferred Skills

• Experience with aseptic processing and material control.
• Knowledge of organ procurement organizations (OPOs), donor screening/testing, and heart/tissue eligibility processes.
• 1 years of industry experience in an FDA-regulated environment within biotechnology or organ procurement.
• Experience training and mentoring junior staff in regulatory and quality processes.
• Familiarity with quality workflows for high-throughput biological data processing.

Compensation (USD): $85,000 - $95,000
This role offers a competitive salary based on experience and qualifications. Additional benefits include health/dental/vision insurance, paid time off, parental leave, 401k retirement plan, company stock options, and bonus eligibility.

Location Policy
If local to San Diego, this position is based at our SD1 site in San Diego, California. If not local to San Diego, this role offers the ability to work remote.

Work Environment / Physical Demands

• Must be able to sit or stand for extended periods, move around the facility, communicate effectively, and lift/carry up to 40 lbs.
• Ability to gown and work in a classified area as required.

Come Work With Us!
Capricor Therapeutics is headquartered in San Diego, California. We offer competitive compensation and benefits, generous vacation and parental leave, flexible working hours, and a collaborative work environment. If you are excited about joining a team that’s transforming the biotech industry and making a real impact on patients’ lives, we’d love to hear from you!