Overnight Quality Assurance Specialist – GMP Cell Therapy

Capricor Therapeutics, Inc.; San Diego (CA); On-site; USD 100,000 - 118,000; Full time

Benefits offered by this job

Benefits package

401(k) match

Job summary

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.

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.
• 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.

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.

Skills

Quality Assurance

GMP experience

cGMP knowledge

QOTF experience

Regulatory compliance

Education

Bachelor's degree in a scientific discipline

Job description

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.