Quality Assurance Associate II- Quality Events Team
Capricor Therapeutics
San Diego - SD1$75,000 - $85,0002 days ago
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Benefits
Remote WorkHealth Insurance
Job Type
full time
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
Why Capricor?
Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.
Come Work With Us!
At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.
Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.
Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.
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Skills
caparisk assessmenttalent acquisitionquality assurance
About Capricor Therapeutics
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class therapeutics, developing transformative cell and exosome-based therapeutics for rare diseases.