Overview
Capricor Therapeutics 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 – 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 be hybrid, Thursday-Monday, 8am-5pm.
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.
- Oversee manufacturing areas during critical operations.
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.
Work Environment & Physical Demands
- 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
