Quality Assurance Specialist - Night Shift

Capricor Therapeutics, Inc.; San Diego (CA); Vor Ort; USD 100.000 - 118.000; Vollzeit

Benefits dieser Stelle

Benefits package

401(k) match

Zusammenfassung

Capricor Therapeutics is seeking a Quality Assurance Specialist for the Graveyard shift to oversee manufacturing, cryopreservation, and support activities, ensuring cGMP compliance.

The ideal candidate will have GMP QA experience and the ability to make independent quality decisions during off-hours. Strong documentation, problem-solving, and cross-team collaboration are essential for success in this fast-paced environment.

Qualifikationen

• 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.
• 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.

Aufgaben

• 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 elevate quality events, deviations, and compliance concerns.
• Support investigations, CAPAs, change controls, and quality risk assessments as required.

Kenntnisse

Quality Assurance

GMP experience

cGMP knowledge

QOTF experience

Regulatory compliance

Ausbildung

Bachelor's degree in a scientific discipline

Jobbeschreibung

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 isDeramiocel(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.

This is an overnight (graveyard) shift role supporting off-hours GMP manufacturing. As a Quality Assurance Specialist 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.

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 elevate 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.

Requirements

• 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.
• 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.

$100,000 - $118,000 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.