Quality Assurance Associate II — CAPA & Deviation Specialist

Capricor; San Diego (CA); Hybrid; USD 85,000 - 105,000; Full time

Job summary

Capricor Therapeutics is seeking a motivated QA Associate II to support the Quality Events Team in triaging issues, investigating deviations, and driving CAPA actions in a cGMP environment. The role spans manufacturing, QC, and R&D, with a hybrid schedule (Thu–Mon, 8am–5pm) in San Diego, CA.

You will perform root cause analyses, risk assessments, and collaboration across cross-functional teams to ensure timely, compliant issue resolution and robust quality documentation.

Qualifications

• Bachelor’s degree or higher in Life Sciences, Engineering, or related field.
• Minimum 3 years of experience in Quality Assurance in biotech/pharmaceutical
• Strong knowledge of cGMP regulations and FDA/EMA guidance
• Experience managing deviations, investigations, and CAPA processes
• Excellent analytical, problem-solving, and root cause investigation skills
• Strong written and verbal communication skills for clear documentation
• Ability to work independently and in a team, with good prioritization

Responsibilities

• Review, investigate, and manage deviations, non-conformances, and CAPA activities.
• Conduct root cause analyses (RCA) and risk assessments for quality issues.
• Collaborate with cross-functional teams to ensure timely resolution of quality events.
• Track and maintain documentation of deviations and CAPAs per regulatory guidelines.
• Monitor trends to identify systemic issues and recommend preventative measures.
• Assist in supporting audits and inspections.
• Develop, update, and maintain SOPs and quality documentation.
• Provide training on deviations and CAPA procedures.
• Support continuous improvement initiatives in quality processes.
• Host or lead Deviation Review Board (DRB) meetings.
• Triage with cross-functional teams to ensure timely resolution.
• Oversee manufacturing areas during critical operations.

Skills

Analytical skills

Problem solving

Root cause analysis

Written communication

Verbal communication

Attention to detail

Organizational skills

Team collaboration

Education

Bachelor’s degree or higher in Life Sciences, Engineering, or related field

Job description

Capricor Therapeutics is seeking a motivated QA Associate II to support the Quality Events Team in triaging issues, investigating deviations, and driving CAPA actions in a cGMP environment. The role spans manufacturing, QC, and R&D, with a hybrid schedule (Thu–Mon, 8am–5pm) in San Diego, CA.

You will perform root cause analyses, risk assessments, and collaboration across cross-functional teams to ensure timely, compliant issue resolution and robust quality documentation.