Capricor Therapeutics

Quality Control Specialist, Analytical

San Diego, CA

Sponsorship not specified$100k-$120kDetected 61 days ago

ExpressData AnalysisRecruitingGMPFDA RegulatoryPCRFlow CytometryProtein AnalysisCommunicationCollaborationProblem SolvingWriting

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.
Working cross-functionally with Quality Assurance, Analytical Development, and Manufacturing, this position emphasizes technical writing, data analysis, and product quality oversight.

Lead and support investigations related to deviations, OOS/OOT/invalid results, and CAPAs, ensuring thorough root cause analysis and clear documentation.
Perform data trending and analysis to identify variability, shifts, or emerging risks in QC and product quality data.
Support method lifecycle activities including qualification, validation, transfer, and periodic review in collaboration with Analytical Development.
Support maintenance of product specifications, including acceptance criteria and scientific justification.
Participate in stability program activities, including data review and trending to support shelf-life determinations.
Support audits and regulatory inspections by preparing and reviewing technical documentation.
Collaborate cross-functionally with QA, Manufacturing, and external partners to support product quality objectives.
Excellent communication skills and ability to collaborate in a cross-functional environment.

~5-8+ years of experience in GMP Quality Control, Quality Assurance, or related function within biotech or pharmaceutical industry.
Experience with deviation investigations, OOS/OOT, CAPAs, and change control processes.
Ability to gown and enter classified areas when required.

Bachelor's degree in Life Sciences, Biotechnology, or related field (advanced degree preferred).

CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases.
At the forefront of our innovation is Deramiocel ( CAP-1002 ), our lead cell therapy in late-stage development for Duchenne muscular dystrophy.
We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology.
The QC Specialist, Analytical supports the quality and compliance of cell therapy programs through a focus on data review, investigations, and quality systems.
This role plays a key part in ensuring that QC methods, analytical data, and documentation meet cGMP requirements and regulatory expectations for clinical and commercial manufacturing.
While maintaining a strong understanding of laboratory operations, the role is not primarily focused on routine bench work.

This listing is sourced directly from Capricor Therapeutics's careers page and normalized into a canonical job model.