Quality Control Associate, Raw Materials

Capricor Therapeutics•San Diego, CA

2d•Onsite

About The Position

Capricor Therapeutics is a biotechnology company focused on developing cell and exosome-based therapies for rare diseases, with a lead therapy in late-stage development for Duchenne muscular dystrophy. The Quality Control Associate, Raw Materials will perform routine testing and documentation of raw materials used in manufacturing processes to ensure they meet specifications, regulatory requirements, and GMP standards. This role involves hands-on laboratory work, maintaining accurate documentation, supporting investigations, and collaborating with various teams to ensure timely material readiness. This is a new position to support the expansion of manufacturing and quality operations.

Requirements

Bachelor’s degree in Life Sciences, Chemistry, Biotechnology, or a related discipline. Will consider experience in lieu of education.
Associate I: some laboratory or QC experience (academic or industry).
Associate II: 1+ years of QC experience in a regulated environment (pharma, biotech, or manufacturing).
Strong attention to detail and ability to follow SOPs and regulated procedures.
Solid understanding of basic laboratory techniques, reagent handling, and instrumentation.
Strong documentation skills and the ability to work efficiently with multiple samples and priorities.
Familiarity with GMP or regulated laboratory environments.

Nice To Haves

Working knowledge of GMP, quality systems, and raw materials workflows.
Experience with analytical techniques such as FTIR, endotoxin testing, wet chemistry, or similar raw material identification methods.
Experience with laboratory data systems (LIMS) and Microsoft Office programs.
Strong communication skills and ability to work effectively in a team environment.

Responsibilities

Perform routine quality control testing of raw materials in accordance with approved specifications and SOPs.
Prepare samples, reagents, standards, and required materials for testing.
Accurately document all test results in laboratory notebooks, forms, and electronic systems following GMP and data integrity standards.
Identify, document, and report any out-of-specification (OOS), atypical, or questionable results to senior QC personnel.
Support investigations, deviations, and CAPA activities as assigned.
Maintain laboratory organization, cleanliness, and adherence to safety and GMP practices.
Assist with equipment operation, calibration, routine checks, and maintenance.
Follow all GMP, safety, and compliance procedures consistently.
Collaborate with QC, QA, Manufacturing, and Supply Chain groups to ensure timely material testing and release.
Participate in training, audits, and ongoing process improvement initiatives.