Quality Assurance Associate II- Quality Events Team

Capricor Therapeutics, Inc.; San Diego (CA); Hybrid; USD 75,000 - 85,000; Full time

Job summary

Capricor Therapeutics is seeking a QA Associate II to join the Quality Events Team (QET) in a hybrid role in San Diego. The candidate will triage issues, investigate deviations, and drive CAPAs across manufacturing, QC, and clinical operations, ensuring cGMP compliance and regulatory alignment.

The role requires a Bachelor’s degree in Life Sciences or Engineering and at least 3 years in QA within biotech/pharma, with strong problem-solving, analytical, and documentation skills.

Qualifications

• Bachelor’s degree or higher in Life Sciences, Engineering, or a related field.
• Minimum 3 years of experience in Quality Assurance within biotech/pharma or related industry.
• Strong knowledge of cGMP regulations, FDA/EMA guidance, and industry quality standards.
• Experience managing deviations, investigations, and CAPA processes.
• Excellent analytical, problem-solving, and root cause investigation skills.
• Strong written and verbal communication, with ability to prepare clear, compliant documentation.

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 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.

Skills

QA Principles

CAPA

Deviation Investigations

Root Cause Analysis

Documentation

Communication Skills

Education

Bachelor’s degree or higher in Life Sciences/Engineering

Job description

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 – 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

$75,000 - $85,000 a year

Compensation and Benefits

The posted salary range represents Capricor’s good-faith estimate of the salary range reasonably expected to be paid for this position at the time of hire. Final compensation will be determined based on job-related factors, including the candidate’s relevant experience, education, skills, certifications, scope of role, location, and internal equity.

This position may also be eligible for a discretionary annual performance bonus and, depending on the level of the role, long-term equity incentive awards in accordance with company policy.

Capricor Therapeutics offers a comprehensive benefits package that includes employer-sponsored medical, dental, and vision coverage; company-paid basic life and AD&D insurance; a 401(k) plan with company match; paid time off and company holidays; and paid parental leave. Additional voluntary benefits and wellness programs may also be available.

Why Capricor?

Capricor Therapeutics is advancing cell and exosome-based therapies with a focus on serious diseases where patients and families need new treatment options. Our work is grounded in scientific rigor, collaboration, and a shared commitment to moving meaningful therapies forward. Joining Capricor means being part of a mission-driven team working at the intersection of innovation, execution, and patient impact.

Come Work With Us

At Capricor, you’ll join a collaborative environment where employees are encouraged to contribute, grow, and help build the systems, science, and operations needed to support our next stage of growth. We value people who are thoughtful, accountable, hands-on, and motivated by work that can make a real difference.

Recruiting Fraud Notice

Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by someone using an official Capricor email address ending in @capricor.com. Capricor will never ask candidates to send money, deposit a check, purchase equipment, or provide payment for any reason as part of the recruiting or onboarding process.

Notice to Recruiting Agencies

Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without express written approval from Talent Acquisition and a fully executed agreement with Capricor. Agencies that contact hiring managers directly, solicit business, or submit candidates without prior approval will not be considered for engagement. Any unsolicited submissions will become the property of Capricor Therapeutics, and no fees will be paid for candidates hired as a result of such submissions. We appreciate your cooperation and respect for this policy.