Quality Assurance Associate II - Night Shift

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. Position Summary This is an overnight (graveyard) shift role supporting off-hours GMP manufacturing. As a Quality Assurance Associate II at Capricor, you will serve as the primary Quality representative during overnight manufacturing operations (Graveyard Shift). In this role, you will provide Quality Assurance oversight for manufacturing, cryopreservation, and support activities while ensuring compliance with cGMP regulations, internal procedures, and quality standards. The ideal candidate brings experience in GMP-regulated environments, strong attention to detail, and the ability to make sound quality decisions independently during off-shift operations. Key Responsibilities - Provide Quality Assurance oversight for manufacturing, cryopreservation, and support operations during the graveyard shift. - Perform Quality on the Floor (QOTF) activities to ensure compliance with cGMP regulations, internal procedures, and regulatory requirements. - Conduct line clearances, in-process inspections, and real-time review of manufacturing activities and documentation. - Support batch record review and verification of manufacturing documentation for completeness, accuracy, and compliance. - Perform Acceptable Quality Level (AQL) inspections of finished drug product and related materials. - Oversee and document drug product and sample transfers following cryopreservation activities. - Review and approve routine quality records, logbooks, forms, and associated documentation as authorized. - Identify, document, and escalate quality events, deviations, and compliance concerns. - Support investigations, CAPAs, change controls, and quality risk assessments as required. - Partner closely with Manufacturing, Quality Control, and Supply Chain teams to support uninterrupted operations during overnight production activities. - Ensure adherence to GMP, GDP, safety, and company policies at all times. - Participate in inspections, audits, and regulatory readiness activities as needed. - Support continuous improvement initiatives that enhance quality systems, compliance, and operational efficiency. Required Qualifications - Bachelor's degree in a scientific discipline or an equivalent combination of education and relevant experience. - Experience in Quality Assurance within a GMP-regulated pharmaceutical, biotechnology, cell therapy, or related manufacturing environment. - Working knowledge of cGMP regulations, Good Documentation Practices (GDP), and quality systems. - Experience performing Quality on the Floor (QOTF) activities and supporting manufacturing operations preferred. - Ability to work independently and make sound quality decisions during off-shift operations. - Flexibility to work evening shifts and weekends as needed to support manufacturing operations. - Strong communication, organizational, documentation, and problem-solving skills. - Ability to effectively collaborate with cross-functional teams in a fast-paced manufacturing environment. - Experience supporting investigations, deviations, CAPAs, and change controls preferred. Core Competencies - Proactive and resourceful: Anticipates operational needs, identifies potential quality issues early, and takes appropriate initiative to support uninterrupted manufacturing operations. - Schedule flexibility and reliability: Comfortable with changing production priorities, adjustments to start and end times, and evening or weekend coverage when operations require it. - Team-first collaboration: Partners closely with Manufacturing, Quality Control, Supply Chain, and colleagues across shifts to support safe, compliant, and uninterrupted operations. - Ownership and accountability: Follows through on commitments, communicates concerns clearly, and escalates quality issues promptly and appropriately. - Sound independent judgment: Makes well-reasoned quality decisions during off-shift operations while maintaining strong attention to detail and compliance with cGMP requirements. Shift Expectations, Work Environment & Physical Requirements Work Environment & Physical Requirements - Work is performed onsite at our San Diego facility on an overnight shift, primarily on the manufacturing floor during production operations. - The role involves Quality on the Floor activities, line clearances, in-process inspections, and documentation review. - The role requires sound independent quality decision-making during off-shift hours. Shift Expectations - The typical schedule is Monday through Friday, 6:00 p.m. to 3:00 a.m. - Manufacturing schedules can ebb and flow. Start and end times, scheduled days, and coverage needs may be adjusted based on production schedules, batch timing, and operational priorities. - Weekend coverage is an expected part of this role when manufacturing operations require it. - When weekend or additional hours are worked, the manager will adjust the employee’s upcoming schedule as operationally appropriate to provide time off and help offset the additional hours. - Flexibility, reliability, and clear communication regarding availability are essential to success in this role. 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.