Quality Assurance Associate II- Quality Events Team
Capricor Therapeutics, Inc.
June 24, 2026
Remote friendly (San Diego, CA)
United States
$75,000 - $85,000 USD yearly
Operations
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 related to deviations and CAPA processes
- Provide training to staff on deviations, deviation reporting, and CAPA procedures
- Support continuous improvement initiatives by enhancing quality processes
- Host/lead Deviation Review Board (DRB) meetings
- Triage with cross-functional teams to ensure timely, quality resolution
- Oversee manufacturing areas during critical operations
Requirements:
- Bachelor’s degree or higher in Life Sciences, Engineering, or a related field
- Minimum 3 years of Quality Assurance experience in biotech, pharmaceutical, or related industry
- Strong knowledge of cGMP regulations and FDA/EMA guidance
- Proven experience managing deviations, investigations, and CAPA processes
- Excellent analytical/problem-solving and root cause investigation skills
- Strong written and verbal communication skills for clear, compliant documentation
- Ability to work independently and in a team
- Attention to detail; strong organizational skills; ability to prioritize multiple tasks in a fast-paced environment
Benefits (as stated): employer-sponsored medical, dental, and vision; company-paid basic life and AD&D; 401(k) with company match; paid time off and company holidays; paid parental leave; additional voluntary benefits and wellness programs may be available.
- 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 related to deviations and CAPA processes
- Provide training to staff on deviations, deviation reporting, and CAPA procedures
- Support continuous improvement initiatives by enhancing quality processes
- Host/lead Deviation Review Board (DRB) meetings
- Triage with cross-functional teams to ensure timely, quality resolution
- Oversee manufacturing areas during critical operations
Requirements:
- Bachelor’s degree or higher in Life Sciences, Engineering, or a related field
- Minimum 3 years of Quality Assurance experience in biotech, pharmaceutical, or related industry
- Strong knowledge of cGMP regulations and FDA/EMA guidance
- Proven experience managing deviations, investigations, and CAPA processes
- Excellent analytical/problem-solving and root cause investigation skills
- Strong written and verbal communication skills for clear, compliant documentation
- Ability to work independently and in a team
- Attention to detail; strong organizational skills; ability to prioritize multiple tasks in a fast-paced environment
Benefits (as stated): employer-sponsored medical, dental, and vision; company-paid basic life and AD&D; 401(k) with company match; paid time off and company holidays; paid parental leave; additional voluntary benefits and wellness programs may be available.