Quality Assurance Associate II

Quality Assurance Associate II

Capricor Therapeutics 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.

We are seeking a Quality Assurance Associate II to join our team. This role is critical in scaling clinical production activities, ensuring compliance with cGMP and regulatory standards. The position will assist in batch record review, deviation investigations, label issuance, and management of controlled documentation across GLP/GCP/GMP systems. The ideal candidate is detail-oriented, organized, and passionate about driving quality excellence in a fast-paced environment.

Responsibilities:

• Assist in batch record review and disposition for clinical product manufacturing, including label issuance, product packaging, and shipping activities.
• Support the issuance, tracking, and archiving of controlled documentation in compliance with GxP (GLP/GCP/GMP) regulations.
• Maintain and manage controlled records, including batch/test records, logs, reports, and quality management documentation.
• Assist in preparing materials for internal audits and ensuring documentation readiness for regulatory inspections.
• Help process and track training records to ensure company-wide GxP compliance.
• Participate in the review and release of incoming materials in accordance with company standards.
• Support controlled label issuance, including inventory tracking and updating lot numbers.
• Collaborate with senior team members to improve and implement quality management systems and training programs.
• Assist in preparing reports and documentation related to deviations, corrective actions, and change controls.
• Support the maintenance and management of documentation systems, both manual and electronic, ensuring timely and accurate record-keeping.
• Perform additional quality assurance tasks as assigned.

Requirements:

• Bachelor's degree in a relevant field (e.g., Biology, Biotechnology, or related discipline) or equivalent experience.
• 0-3 years of experience in a regulated environment (e.g., cGMP, GLP, GCP).
• Familiarity with regulatory standards such as 21 CFR 210 and 211, ICH, ISO9001, and FDA guidelines preferred.
• Strong attention to detail and excellent organizational skills for managing documentation and records.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with database systems.
• Strong written and verbal communication skills for effective collaboration and reporting.
• Ability to work independently and as part of a team in a dynamic, fast-paced environment.
• Comfortable gowning and working in classified areas as required.

Work Environment / Physical Demands:

• Primarily office-based with occasional time in GMP cleanroom environments for documentation and oversight tasks.
• Requires prolonged periods of computer use for documentation and record management, and gowning for cleanroom work.
• May involve lifting materials or equipment up to 20 pounds.
• Ability to navigate office and classified GMP environments for quality assurance activities.

$70,305 - $82,000 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.