Capricor Therapeutics
Quality Control Associate - Raw Materials
Capricor Therapeutics, San Diego, California, United States, 92189
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 for Raw Materials is responsible for performing routine testing and documentation of raw materials used in Capricor’s manufacturing processes. This role ensures all incoming materials meet established specifications, regulatory requirements, and GMP standards. As part of the QC Raw Materials team, you will perform hands‑on laboratory work, maintain accurate and compliant documentation, support investigations, and collaborate with QC, QA, Procurement, and Manufacturing teams to ensure timely material readiness.
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.
Required Qualifications
Bachelor’s degree in Life Sciences, Chemistry, Biotechnology, or a related discipline.
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.
Preferred Qualifications
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.
Work Environment & Physical Demands
Laboratory‑based role with regular work in GMP areas.
Prolonged periods of computer use for documentation, analysis, and reporting.
Occasional lifting of materials or equipment up to 20 pounds.
Ability to navigate laboratory and manufacturing support areas for sampling, inspections, and oversight duties.
$65,000 - $85,000 a year
Why Capricor? Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient‑centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission‑driven group that’s transforming lives with every breakthrough.
Come Work With Us! At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting‑edge therapies.
#J-18808-Ljbffr
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 for Raw Materials is responsible for performing routine testing and documentation of raw materials used in Capricor’s manufacturing processes. This role ensures all incoming materials meet established specifications, regulatory requirements, and GMP standards. As part of the QC Raw Materials team, you will perform hands‑on laboratory work, maintain accurate and compliant documentation, support investigations, and collaborate with QC, QA, Procurement, and Manufacturing teams to ensure timely material readiness.
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.
Required Qualifications
Bachelor’s degree in Life Sciences, Chemistry, Biotechnology, or a related discipline.
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.
Preferred Qualifications
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.
Work Environment & Physical Demands
Laboratory‑based role with regular work in GMP areas.
Prolonged periods of computer use for documentation, analysis, and reporting.
Occasional lifting of materials or equipment up to 20 pounds.
Ability to navigate laboratory and manufacturing support areas for sampling, inspections, and oversight duties.
$65,000 - $85,000 a year
Why Capricor? Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient‑centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission‑driven group that’s transforming lives with every breakthrough.
Come Work With Us! At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting‑edge therapies.
#J-18808-Ljbffr