Capricor Therapeutics
Quality Assurance Specialist - Night Shift
San Diego - SD1
Sponsorship not specified$100k-$118kDetected 36 days ago
ExpressSupply ChainRecruitingGMPCommunicationCollaborationProblem Solving
About the role
- Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases.
- 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.
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.
- 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.
- Identify, document, and escalate quality events, deviations, and compliance concerns.
- Partner closely with Manufacturing, Quality Control, and Supply Chain teams to support uninterrupted operations during overnight production activities.
- Support continuous improvement initiatives that enhance quality systems, compliance, and operational efficiency.
Requirements
- 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.
Nice to have
- Experience performing Quality on the Floor (QOTF) activities and supporting manufacturing operations preferred.
- Experience supporting investigations, deviations, CAPAs, and change controls preferred.
Compensation
- $100k-$118k
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