Quality Assurance Specialist

Capricor Therapeutics•San Diego, CA

17d•$100,000 - $118,000•Onsite

About The Position

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.

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.
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.

Nice To Haves

Experience performing Quality on the Floor (QOTF) activities and supporting manufacturing operations preferred.
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 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.