Quality Control Associate II, Controls
Capricor Therapeutics, Inc.
4 hours ago
On-site
San Diego, CA
$75,000 - $87,000 USD yearly
Operations
Responsibilities:
- Generate, prepare, and maintain positive and negative control materials used in QC analytical assays
- Support the qualification and characterization of control materials 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 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 (laboratory notebooks, controlled forms, and electronic records)
- Support preparation and maintenance of technical documentation (study protocols, reports, SOP updates, and control qualification records)
- Assist with investigations related to assay performance (deviations, OOS/OOT events, and atypical results)
- Collaborate with QC scientists and cross-functional teams (Analytical Development, Process Development, Manufacturing, and Quality) to support assay readiness and continuous improvement
- Manage multiple laboratory assignments and testing priorities to meet project timelines and QC operational needs
Required 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/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
- Strong organizational and time management skills
Preferred Qualifications:
- Experience supporting analytical studies related to assay performance or assay optimization
- Experience with mammalian cell culture or cell-based assays
- Experience supporting method qualification or assay performance monitoring
- Experience supporting deviations, investigations, or technical reports in regulated environments
- Experience working with cell therapy, biologics, or exosome-based products
Work Environment & Physical Requirements:
- 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
- Generate, prepare, and maintain positive and negative control materials used in QC analytical assays
- Support the qualification and characterization of control materials 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 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 (laboratory notebooks, controlled forms, and electronic records)
- Support preparation and maintenance of technical documentation (study protocols, reports, SOP updates, and control qualification records)
- Assist with investigations related to assay performance (deviations, OOS/OOT events, and atypical results)
- Collaborate with QC scientists and cross-functional teams (Analytical Development, Process Development, Manufacturing, and Quality) to support assay readiness and continuous improvement
- Manage multiple laboratory assignments and testing priorities to meet project timelines and QC operational needs
Required 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/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
- Strong organizational and time management skills
Preferred Qualifications:
- Experience supporting analytical studies related to assay performance or assay optimization
- Experience with mammalian cell culture or cell-based assays
- Experience supporting method qualification or assay performance monitoring
- Experience supporting deviations, investigations, or technical reports in regulated environments
- Experience working with cell therapy, biologics, or exosome-based products
Work Environment & Physical Requirements:
- 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