Quality Assurance Associate II – Quality Events Team
Capricor Therapeutics, Inc.
full-time
Posted on:
Location Type: Hybrid
Location: San Diego • California • United States
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Salary
💰 $75,000 - $87,000 per year
About the role
- 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.
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.
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
root cause analysisrisk assessmentdeviation managementCAPA managementSOP developmentquality documentationquality assurancecGMP regulationsFDA guidanceanalytical skills
Soft Skills
problem-solvingcommunication skillsorganizational skillsattention to detailteamworkindependencetime managementtraining skillscollaborationcontinuous improvement