Capricor Therapeutics

Quality Assurance Associate II

San Diego, CA · Mid

Sponsorship not specified$70k-$82kDetected 268 days ago

ExpressGCPExcelRecruitingGMPFDA RegulatoryCommunicationCollaborationOrganizational SkillsMicrosoft OfficeGxP

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.
This role is critical in scaling clinical production activities, ensuring compliance with cGMP and regulatory standards.

Support the issuance, tracking, and archiving of controlled documentation in compliance with GxP (GLP/GCP/GMP) regulations.
Maintain and manage controlled records, including batch/test records, logs, reports, and quality management documentation.
Support controlled label issuance, including inventory tracking and updating lot numbers.
Collaborate with senior team members to improve and implement quality management systems and training programs.
Support the maintenance and management of documentation systems, both manual and electronic, ensuring timely and accurate record-keeping.
Perform additional quality assurance tasks as assigned.

Bachelor's degree in a relevant field (e.g., Biology, Biotechnology, or related discipline) or equivalent experience.
0-3 years of experience in a regulated environment (e.g., cGMP, GLP, GCP).
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with database systems.
Comfortable gowning and working in classified areas as required.
Ability to navigate office and classified GMP environments for quality assurance activities.

Familiarity with regulatory standards such as 21 CFR 210 and 211, ICH, ISO9001, and FDA guidelines preferred.

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.
We are seeking a Quality Assurance Associate II to join our team.
The position will assist in 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.

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