Position Summary
The Quality Control Associate, 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. This is a new headcount created to support the expansion of Capricor’s manufacturing and quality operations.
Team Mission
The QC Raw Materials team ensures that all raw materials used in manufacturing consistently meet quality, safety, and regulatory standards. By verifying material identity, quality, and compliance, the team enables reliable production and supports Capricor’s broader mission of delivering high‑quality therapeutic products.
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.
Minimum Qualifications
- 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.
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.
