Quality Assurance Associate II- Quality Events Team
About The Position
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX⢠exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. Capricor is seeking a self-motivated team player with attention to detail, who enjoys organizing, making processes better, and making a difference in patient lives. The Quality Assurance QA Associate II â Quality Events Team (QET) is responsible for cross-functional triage of issues and managing, investigating, and resolving deviations, non-conformances, and corrective and preventive actions (CAPAs) in compliance with cGMP, SOPs, and regulatory requirements. This role ensures the consistent application of quality standards across manufacturing, laboratory, and clinical operations while supporting continuous improvement initiatives. The position will report to the Manager of Quality Assurance.
Requirements
- Education: Bachelorâs 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
