Quality Assurance Associate II - Night Shift

Capricor Therapeutics • San Diego - SD1, CA

3d • Onsite

About The Position

Capricor Therapeutics is seeking a Quality Assurance Associate II to serve as the primary Quality representative during overnight GMP manufacturing operations at its San Diego facility. The role provides Quality Assurance oversight for manufacturing, cryopreservation, and support activities, ensuring compliance with cGMP regulations, internal procedures, and quality standards. The position requires independent, sound quality decisions during off-shift operations and includes working primarily on the manufacturing floor during production.

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, and quality systems.
• 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 collaborate effectively with cross-functional teams in a fast-paced manufacturing environment.

Nice To Haves

• Experience performing Quality on the Floor activities and supporting manufacturing operations.
• Experience supporting investigations, deviations, CAPAs, and change controls.

Responsibilities

• Provide Quality Assurance oversight for manufacturing, cryopreservation, and support operations during the graveyard shift.
• Perform Quality on the Floor activities to ensure compliance with cGMP regulations, internal procedures, and regulatory requirements.
• Conduct line clearances and in-process inspections, and review manufacturing activities and documentation in real time.
• Support batch record review and verify manufacturing documentation for completeness, accuracy, and compliance.
• Perform Acceptable Quality Level inspections of finished drug product and related materials.
• Oversee and document drug product and sample transfers following cryopreservation activities.
• Review and approve authorized routine quality records, logbooks, forms, and related documentation.
• Identify, document, and escalate quality events, deviations, and compliance concerns.
• Support investigations, CAPAs, change controls, and quality risk assessments.
• Partner with Manufacturing, Quality Control, and Supply Chain teams to support overnight production operations.
• Ensure adherence to GMP, GDP, safety, and company policies.
• Participate in inspections, audits, and regulatory readiness activities as needed.
• Support continuous improvement initiatives that enhance quality systems, compliance, and operational efficiency.

Benefits

• Employer-sponsored medical coverage
• Employer-sponsored dental coverage
• Employer-sponsored vision coverage
• Company-paid basic life and AD&D insurance
• 401(k) plan with company match
• Paid time off
• Company holidays
• Paid parental leave
• Additional voluntary benefits and wellness programs may be available
• May be eligible for a discretionary annual performance bonus
• Depending on role level, may be eligible for long-term equity incentive awards

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level