QA Associate II — Deviations & CAPA Specialist (Hybrid)

Capricor Therapeutics, Inc.; San Diego (CA); Hybrid; USD 75,000 - 85,000; Full time

Job summary

Capricor Therapeutics is seeking a QA Associate II to join the Quality Events Team (QET) in a hybrid role in San Diego. The candidate will triage issues, investigate deviations, and drive CAPAs across manufacturing, QC, and clinical operations, ensuring cGMP compliance and regulatory alignment.

The role requires a Bachelor’s degree in Life Sciences or Engineering and at least 3 years in QA within biotech/pharma, with strong problem-solving, analytical, and documentation skills.

Qualifications

• Bachelor’s degree or higher in Life Sciences, Engineering, or a related field.
• Minimum 3 years of experience in Quality Assurance within biotech/pharma or related industry.
• Strong knowledge of cGMP regulations, FDA/EMA guidance, and industry quality standards.
• Experience managing deviations, investigations, and CAPA processes.
• Excellent analytical, problem-solving, and root cause investigation skills.
• Strong written and verbal communication, with ability to prepare clear, compliant documentation.

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 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.

Skills

QA Principles

CAPA

Deviation Investigations

Root Cause Analysis

Documentation

Communication Skills

Education

Bachelor’s degree or higher in Life Sciences/Engineering

Job description

Capricor Therapeutics is seeking a QA Associate II to join the Quality Events Team (QET) in a hybrid role in San Diego. The candidate will triage issues, investigate deviations, and drive CAPAs across manufacturing, QC, and clinical operations, ensuring cGMP compliance and regulatory alignment.

The role requires a Bachelor’s degree in Life Sciences or Engineering and at least 3 years in QA within biotech/pharma, with strong problem-solving, analytical, and documentation skills.