Capricor Therapeutics

Quality Assurance Associate II- Quality Events Team

San Diego - SD1 · Mid

Sponsorship not specified$75k-$85kDetected 29 days ago

ExpressRecruitingGMPFDA RegulatoryCommunicationCollaborationProblem SolvingOrganizational Skills

About the role

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases.
Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.
Capricor is seeking a self-motivated team player with attention to detail, who enjoys organizing, making processes better, and making a difference in patient lives.

Review, investigate, and manage deviations, non-conformances, and CAPA activities across the organization.
Collaborate with cross-functional teams (Manufacturing, MSAT, QC, Clinical, and R&D) to ensure timely resolution of quality events.
Track and maintain documentation of deviations and CAPAs in compliance with cGMP, FDA, and other applicable regulatory guidelines.
Develop, update, and maintain SOPs and quality documentation, including but not limited to those related to deviations and CAPA processes.
Support continuous improvement initiatives by identifying opportunities to enhance quality processes.
Host/Lead Deviation Review Board (DRB) meetings.

Professional Experience: Minimum of 3 years of experience in Quality Assurance within a biotech, pharmaceutical, or related industry.
Strong knowledge of cGMP regulations, FDA/EMA guidance, and industry quality standards.
Proven experience managing deviations, investigations, and CAPA processes.
Strong written and verbal communication skills, with the ability to prepare clear, compliant documentation.
Attention to detail, organizational skills, and the ability to prioritize multiple tasks in a fast-paced environment.
Ability to sit for extended periods during virtual or in-person meetings and computer work
Bachelor's degree or higher in Life Sciences, Engineering, or a related field.

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.
The Quality Assurance QA Associate II - Quality Events Team (QET) is responsible for cross-functional triage of issues and managing, investigating, and resolving deviations, non-conformances, and corrective and preventive actions (CAPAs) in compliance with cGMP, SOPs, and regulatory requirements.
This role ensures the consistent application of quality standards across manufacturing, laboratory, and clinical operations while supporting continuous improvement initiatives.
The position will be hybrid, Thursday-Monday, 8am-5pm.

This listing is sourced directly from Capricor Therapeutics's careers page and normalized into a canonical job model.