Quality Control Associate II, Controls

Capricor; San Diego (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Capricor Therapeutics in San Diego seeks a QC Analyst to generate and manage QC control materials, perform analytical assays (ELISA, PCR/qPCR, flow cytometry), and support GMP‑compliant documentation. You will collaborate with Analytical Development, Process Development, Manufacturing, and Quality to ensure assay readiness and quality control efficiency.

The role requires 2+ years in a GMP‑regulated lab, strong data analysis, and independent work abilities within a fast-paced biopharma setting.

Qualifications

• Bachelor’s degree in Biological Sciences, Biochemistry, Molecular Biology, or related discipline.
• 2+ years of laboratory experience in biotechnology, pharmaceutical, or GMP-regulated environments.
• Hands-on experience performing analytical assays such as ELISA, PCR/qPCR, flow cytometry, or other biochemical or cell-based assays.
• Experience preparing or maintaining assay controls or reference materials.
• Strong laboratory documentation practices and familiarity with GMP and data integrity expectations.
• Ability to analyze data and communicate findings clearly.
• Ability to work independently and manage multiple assignments in a laboratory environment.
• Strong organizational and time-management skills.

Responsibilities

• Generate, prepare, and maintain positive and negative control materials used in QC analytical assays.
• Support the qualification and characterization of control materials to ensure suitability for routine QC testing.
• Execute analytical assays to support control evaluation, assay troubleshooting, and assay optimization studies.
• Perform laboratory activities related to control generation, characterization, and assay performance evaluation.
• Maintain inventory, traceability, and documentation of assay control materials used across QC testing programs.
• Analyze experimental data, summarize results, and document findings in accordance with GMP and data integrity requirements.
• Document all laboratory work in GMP‑compliant systems including laboratory notebooks, controlled forms, and electronic records.
• Support preparation and maintenance of technical documentation including study protocols, reports, SOP updates, and control qualification records.
• Assist with investigations related to assay performance including deviations, OOS/OOT events, and atypical assay results.
• Collaborate with QC scientists and cross‑functional teams including Analytical Development, Process Development, Manufacturing, and Quality to support assay readiness and continuous improvement initiatives.
• Manage multiple laboratory assignments and testing priorities to meet project timelines and QC operational needs.
• Perform additional QC duties as assigned.

Skills

ELISA

PCR/qPCR

Flow cytometry

GMP documentation

Data analysis

Education

Bachelor’s degree in Biological Sciences, Biochemistry, Molecular Biology, or related discipline

Tools

Assay controls

Reference materials

Job description

Job Summary

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.

Responsibilities

• Generate, prepare, and maintain positive and negative control materials used in QC analytical assays.
• Support the qualification and characterization of control materials to ensure suitability for routine QC testing.
• Execute analytical assays to support control evaluation, assay troubleshooting, and assay optimization studies.
• Perform laboratory activities related to control generation, characterization, and assay performance evaluation.
• Maintain inventory, traceability, and documentation of assay control materials used across QC testing programs.
• Analyze experimental data, summarize results, and document findings in accordance with GMP and data integrity requirements.
• Document all laboratory work in GMP‑compliant systems including laboratory notebooks, controlled forms, and electronic records.
• Support preparation and maintenance of technical documentation including study protocols, reports, SOP updates, and control qualification records.
• Assist with investigations related to assay performance including deviations, OOS/OOT events, and atypical assay results.
• Collaborate with QC scientists and cross‑functional teams including Analytical Development, Process Development, Manufacturing, and Quality to support assay readiness and continuous improvement initiatives.
• Manage multiple laboratory assignments and testing priorities to meet project timelines and QC operational needs.
• Perform additional QC duties as assigned.

Qualifications

• Bachelor’s degree in Biological Sciences, Biochemistry, Molecular Biology, or related discipline.
• 2+ years of laboratory experience in biotechnology, pharmaceutical, or GMP‑regulated environments.
• Hands‑on experience performing analytical assays such as ELISA, PCR/qPCR, flow cytometry, or other biochemical or cell‑based assays.
• Experience preparing or maintaining assay controls or reference materials.
• Strong laboratory documentation practices and familiarity with GMP and data integrity expectations.
• Ability to analyze data and communicate findings clearly.
• Ability to work independently and manage multiple assignments in a laboratory environment.
• Strong organizational and time‑management skills.

Preferred Qualifications

• Experience supporting analytical studies related to assay performance or assay optimization.
• Experience working with mammalian cell culture or cell‑based assays.
• Experience supporting method qualification or assay performance monitoring activities.
• Experience supporting deviations, investigations, or technical reports in regulated environments.
• Experience working with cell therapy, biologics, or exosome‑based products.
• Laboratory‑based role requiring routine bench work.
• Work involves analytical instrumentation, laboratory documentation, and computer‑based data analysis.
• Ability to lift up to 20 pounds.
• Occasional participation in cross‑functional meetings and technical discussions.

Why Capricor?

Capricor Therapeutics is advancing cell and exosome‑based therapies with a focus on serious diseases where patients and families need new treatment options. Our work is grounded in scientific rigor, collaboration, and a shared commitment to moving meaningful therapies forward. Joining Capricor means being part of a mission‑driven team working at the intersection of innovation, execution, and patient impact.

Come Work With Us

At Capricor, you’ll join a collaborative environment where employees are encouraged to contribute, grow, and help build the systems, science, and operations needed to support our next stage of growth. We value people who are thoughtful, accountable, hands‑on, and motivated by work that can make a real difference.