Quality Assurance Specialist

About the Company

Capricor Therapeutics is a biotechnology organization focused on developing advanced cell- and exosome-based treatments for rare diseases. Its lead program, Deramiocel (CAP-1002), is an advanced cell therapy candidate for Duchenne muscular dystrophy. The company also develops its proprietary StealthX exosome platform to support targeted delivery and vaccine-related innovation. Its work is centered on scientific progress and therapies designed to improve outcomes for patients and families.

Role Overview

As a Quality Assurance Specialist, you will be the main QA contact supporting overnight manufacturing activities on the graveyard shift. The position involves monitoring manufacturing, cryopreservation, and related support work to confirm adherence to cGMP requirements, internal policies, and quality expectations. This role suits someone with GMP manufacturing experience, strong attention to detail, and the confidence to make independent quality decisions outside normal business hours.

Key Responsibilities

• Act as the QA lead for overnight manufacturing, cryopreservation, and support operations during the graveyard shift.
• Carry out Quality on the Floor checks to verify compliance with cGMP rules, internal procedures, and applicable regulatory standards.
• Complete line clearances, in-process checks, and live review of production activities and related records.
• Assist with batch record assessment and confirm that manufacturing documentation is complete, accurate, and compliant.
• Perform acceptable quality level inspections on finished drug products and associated materials.
• Monitor and document transfers of drug product and samples after cryopreservation steps.
• Review and approve routine quality records, logbooks, forms, and other documentation when permitted.
• Recognize, record, and escalate quality issues, deviations, and compliance concerns.
• Contribute to investigations, CAPAs, change control activities, and quality risk assessments as needed.
• Work closely with Manufacturing, Quality Control, and Supply Chain teams to keep overnight production running smoothly.
• Ensure consistent compliance with GMP, GDP, safety rules, and company policies.
• Support inspections, audits, and regulatory preparedness efforts as required.
• Take part in continuous improvement efforts aimed at strengthening quality systems, compliance, and efficiency.

Requirements

• A bachelor’s degree in a scientific field, or an equivalent mix of education and relevant experience.
• Background in Quality Assurance within a GMP-controlled pharmaceutical, biotechnology, cell therapy, or similar manufacturing setting.
• Working understanding of cGMP requirements, Good Documentation Practices, and quality systems.
• Prior exposure to Quality on the Floor activities and manufacturing support is preferred.
• Ability to operate independently and make sound quality judgments during off-shift work.
• Strong skills in communication, organization, documentation, and problem-solving.
• Comfort working with cross-functional partners in a fast-moving manufacturing environment.
• Experience with investigations, deviations, CAPAs, and change controls is preferred.

Additional Information

Capricor emphasizes scientific excellence, integrity, and patient-focused innovation. The team environment is collaborative and designed to support professional growth while contributing to life-changing therapies.

Interview and Recruiting Notice

The company does not conduct interviews or recruiting conversations through Skype. Official communication will come only from an @capricor.com email address. Capricor will never request that candidates send money or checks for any reason.

Agency Policy

Capricor Therapeutics does not accept candidate referrals or submissions from recruiting agencies, staffing firms, or third-party recruiters unless there is prior written approval from Talent Acquisition management and an established agreement. Unapproved submissions will not be considered, and no fees will be paid for hires resulting from such submissions. Any submitted candidates become the property of Capricor Therapeutics.