Quality Assurance Associate II – Quality Events Team

Capricor Therapeutics, Inc.

Quality Assurance Associate II managing deviations and CAPAs for biotech firm Capricor Therapeutics. Collaborating with cross-functional teams to ensure compliance with quality standards in manufacturing operations.

Posted 6/23/2026full-timeSan Diego • California • 🇺🇸 United StatesJuniorMid-Level💰 $75,000 - $85,000 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

root cause analysisrisk assessmentdeviation managementCAPA managementSOP developmentquality documentationdata analysisquality assurancecompliance monitoringcontinuous improvement

Soft Skills

analytical skillsproblem-solvingcommunication skillsorganizational skillsattention to detailteam collaborationindependencetime managementtraining skillsleadership

Industry Keywords

cGMPFDAEMAbiotechpharmaceuticalquality standardsdeviation review boardinternal auditsexternal inspectionsquality processes

About the role

Key responsibilities & impact

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.
Oversee manufacturing areas during critical operations.

Requirements

What you’ll need

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

Comp & perks

Professional office environment (San Diego, CA) and remote work setup (Thurs-Mon, 8am-5pm), subject to flexibility of the manufacturing fill schedule.
Ability to sit for extended periods during virtual or in-person meetings and computer work