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Experience Level
Experience
Qualifications
Candidates should possess a background in Quality Assurance within the biotechnology or pharmaceutical industry, with familiarity in GMP regulations. Strong analytical skills and attention to detail are essential. Previous experience with donor screening processes and regulatory compliance is preferred.
About the job
Capricor Therapeutics (NASDAQ: CAPR) is a pioneering biotechnology firm focused on advancing innovative cell and exosome-based therapies for rare diseases. Our flagship product, Deramiocel (CAP-1002), is currently in late-stage development for Duchenne muscular dystrophy. Leveraging our proprietary StealthX™ exosome platform, we are exploring new avenues in targeted delivery and vaccinology. Each initiative embodies our dedication to pushing the boundaries of scientific innovation and providing transformative treatments to patients and families who need them the most.
The Quality Assurance Associate II/III plays a crucial role in overseeing and reviewing quality assurance activities that support donor eligibility assessments and GMP manufacturing operations for cell therapy products. This position ensures that donor-derived starting materials utilized in cell therapy manufacturing comply with both regulatory and internal quality standards prior to their application.
The QA II/III conducts independent evaluations of donor screening documentation, infectious disease testing outcomes, and associated records to confirm donor suitability before the release of starting materials for manufacturing. Donor eligibility assessments are vital quality decisions that impact the appropriateness of donor-derived materials for cell therapy.
This role has the authority to execute QA reviews and approvals of donor eligibility and suitability determinations in alignment with established procedures and regulatory mandates.
Additionally, the position supports routine QA operations, including batch record assessments, deviation management, change control assistance, and inspection preparedness.
About Capricor Therapeutics
Capricor Therapeutics is at the cutting edge of biotechnology, dedicated to developing innovative therapies that transform the lives of patients with rare diseases. Our commitment to scientific excellence drives us to create meaningful solutions that address critical healthcare challenges.
Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.
Unlock Your Potential
Generate Job-Optimized Resume
One Click And Our AI Optimizes Your Resume to Match The Job Description.
Is Your Resume Optimized For This Role?
Find Out If You're Highlighting The Right Skills And Fix What's Missing
Experience Level
Experience
Qualifications
Candidates should possess a background in Quality Assurance within the biotechnology or pharmaceutical industry, with familiarity in GMP regulations. Strong analytical skills and attention to detail are essential. Previous experience with donor screening processes and regulatory compliance is preferred.
About the job
Capricor Therapeutics (NASDAQ: CAPR) is a pioneering biotechnology firm focused on advancing innovative cell and exosome-based therapies for rare diseases. Our flagship product, Deramiocel (CAP-1002), is currently in late-stage development for Duchenne muscular dystrophy. Leveraging our proprietary StealthX™ exosome platform, we are exploring new avenues in targeted delivery and vaccinology. Each initiative embodies our dedication to pushing the boundaries of scientific innovation and providing transformative treatments to patients and families who need them the most.
The Quality Assurance Associate II/III plays a crucial role in overseeing and reviewing quality assurance activities that support donor eligibility assessments and GMP manufacturing operations for cell therapy products. This position ensures that donor-derived starting materials utilized in cell therapy manufacturing comply with both regulatory and internal quality standards prior to their application.
The QA II/III conducts independent evaluations of donor screening documentation, infectious disease testing outcomes, and associated records to confirm donor suitability before the release of starting materials for manufacturing. Donor eligibility assessments are vital quality decisions that impact the appropriateness of donor-derived materials for cell therapy.
This role has the authority to execute QA reviews and approvals of donor eligibility and suitability determinations in alignment with established procedures and regulatory mandates.
Additionally, the position supports routine QA operations, including batch record assessments, deviation management, change control assistance, and inspection preparedness.
About Capricor Therapeutics
Capricor Therapeutics is at the cutting edge of biotechnology, dedicated to developing innovative therapies that transform the lives of patients with rare diseases. Our commitment to scientific excellence drives us to create meaningful solutions that address critical healthcare challenges.