Quality Control Associate III, Sample Management

Capricor Therapeutics (NASDAQ: 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. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

The Quality Control Associate II will perform analytical testing to support batch disposition, in‑process control, drug substance and drug product release, and stability studies. This role is central to ensuring product quality and regulatory compliance for Capricor’s cell‑based and exosome‑based therapeutic platforms. As a key member of the analytical team, you will execute complex assays and manage mammalian cell cultures essential for determining product potency and characterization. You will be responsible for ensuring that all data is recorded with the highest level of integrity in GMP-compliant systems while proactively supporting investigations into any atypical results. Working in this hands-on bench role, you will collaborate cross-functionally with development and manufacturing partners to ensure testing readiness and drive continuous improvement across our analytical operations.

Responsibilities

Receive, log, label, and track incoming samples using a laboratory information management system (LIMS) or equivalent tracking system Verify sample documentation for accuracy, completeness, and compliance with protocols Maintain proper storage conditions (e.g., temperature-controlled environments such as refrigerators, freezers, and ambient storage) Monitor and document storage conditions, including temperature logs and alarm responses Coordinate sample distribution (i.e. in-house, release, and stability) to internal departments or external laboratories Ensure chain-of-custody documentation is accurate and maintained Perform inventory management, including reconciliation and periodic audits Dispose of samples according to safety, regulatory, and company procedures Investigate and document sample discrepancies, deviations, or nonconformances Support laboratory operations by preparing materials as needed Maintain clean, organized, and compliant storage areas

Required Qualifications (Must‑Haves) Bachelor’s degree in Biology, Chemistry, Microbiology, or a related scientific field (or equivalent experience) 3–5 years of experience in a laboratory, sample management, or regulated environment required Familiarity with LIMS or electronic tracking systems Knowledge of GMP/GLP regulations is required

Skills and Competencies

Strong attention to detail and organizational skills Ability to manage multiple priorities and meet deadlines Good documentation practices (GDP) knowledge Strong communication and teamwork skills Problem-solving and critical thinking abilities

Work Environment & Physical Requirements Ability to sit or stand for extended periods and move throughout the facility. Ability to gown and enter classified areas when required. Ability to lift and carry up to 40 lbs as needed.