Quality Assurance Associate II- Quality Events Team

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.

Responsibilities

• Review, investigate, and manage deviations, non-conformances, and CAPA activities across the organization.
• Conduct root cause analyses (RCA) and risk assessments for reported quality issues.
• 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.
• Monitor trends in deviations and CAPAs to identify systemic issues and recommend preventative measures.
• Assist in preparing and supporting internal and external audits and inspections.
• Develop, update, and maintain SOPs and quality documentation, including but not limited to those related to deviations and CAPA processes.
• Provide training to staff on deviations, deviation reporting, and CAPA procedures.
• Support continuous improvement initiatives by identifying opportunities to enhance quality processes.
• Host/Lead Deviation Review Board (DRB) meetings.
• Triage with cross-functional teams to ensure issues are resolved in a timely, quality manner.
• Oversee manufacturing areas during critical operations.

Requirements

• Education: Bachelor’s degree or higher in Life Sciences, Engineering, or a related field.
• 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.
• Excellent analytical, problem-solving, and root cause investigation skills.
• Strong written and verbal communication skills, with the ability to prepare clear, compliant documentation.
• Ability to work independently and as part of a team.
• Attention to detail, organizational skills, and the ability to prioritize multiple tasks in a fast-paced environment.

Work Environment & Physical Demands

• Professional office environment (San Diego, CA) and remote work setup (Thurs-Mon, 8am-5pm), subject to flexibility of the manufacturing fill schedule.
• Ability to sit for extended periods during virtual or in-person meetings and computer work