Capricor Therapeutics, Inc. · 4 hours ago
Quality Assurance Associate II- Quality Events Team
San Diego, CA
Full-time
Hybrid
Mid Level
$75K/yr - $87K/yr
3+ years expCapricor Therapeutics is a biotechnology company focused on advancing innovative cell and exosome-based therapies for rare diseases. They are seeking a Quality Assurance Associate II for their Quality Events Team, responsible for managing and resolving quality issues in compliance with regulatory standards while supporting continuous improvement initiatives.
BiotechnologyHealth CareMedicalTherapeutics
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
Qualification
Required
Bachelor's degree or higher in Life Sciences, Engineering, or a related field
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
Company
Capricor Therapeutics, Inc.
Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.
51-200 employees
H1B Sponsorship
Capricor Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$329.5MKey Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M
Leadership Team
AJ Bergmann
Chief Financial Officer
Recent News
2026-01-09
Company data provided by crunchbase