Quality Control Associate II/III, Analytical
Capricor Therapeutics, Inc.
6 months ago
On-site
San Diego, CA
$75,000 - $87,000 USD yearly
Operations
Responsibilities:
- Perform QC analytical testing on in-process materials, bulk drug substances, and final products to support batch release and stability programs.
- Maintain and prepare mammalian cell cultures used in potency or characterization assays.
- Conduct analytical assays such as ELISA, qPCR, flow cytometry, and RNA-based methods.
- Analyze data, generate results, and enter findings into QC systems and reports.
- Document all work in accordance with GMP and data integrity standards (batch records, lab notebooks, controlled forms).
- Communicate test results, issues, or atypical findings to QC leadership and development partners.
- Support or author technical documentation, including deviations, OOS/OOT investigations, method qualification/validation documents, or procedural updates.
- Assist with assay troubleshooting with Process and Analytical Development.
- Train team members on relevant lab techniques or QC procedures.
- Support updates to QC SOPs and continuous improvement initiatives.
- Manage testing priorities to meet project timelines and operational needs.
- Perform additional QC duties as assigned.
Required Qualifications (Must-Haves):
- Bachelor’s degree in Biological Sciences or related field.
- 2+ years of experience in a GMP QC laboratory or GMP/GLP environment.
- Hands-on experience with mammalian cell culture.
- Experience performing analytical assays such as ELISA, qPCR, flow cytometry, RNA sequencing, or similar technologies.
- Strong GMP documentation, data integrity, and compliant data recording skills.
- Ability to work independently, manage multiple testing assignments, and meet tight timelines.
Preferred Qualifications (Nice-to-Haves):
- Experience with cell-based or exosome-based products.
- Experience coordinating or managing samples with outsourced/contract testing labs.
- Knowledge of method qualification or validation requirements.
- Experience writing deviations, OOS investigations, or validation protocols.
- Experience with aseptic processing and work in classified environments.
- Perform QC analytical testing on in-process materials, bulk drug substances, and final products to support batch release and stability programs.
- Maintain and prepare mammalian cell cultures used in potency or characterization assays.
- Conduct analytical assays such as ELISA, qPCR, flow cytometry, and RNA-based methods.
- Analyze data, generate results, and enter findings into QC systems and reports.
- Document all work in accordance with GMP and data integrity standards (batch records, lab notebooks, controlled forms).
- Communicate test results, issues, or atypical findings to QC leadership and development partners.
- Support or author technical documentation, including deviations, OOS/OOT investigations, method qualification/validation documents, or procedural updates.
- Assist with assay troubleshooting with Process and Analytical Development.
- Train team members on relevant lab techniques or QC procedures.
- Support updates to QC SOPs and continuous improvement initiatives.
- Manage testing priorities to meet project timelines and operational needs.
- Perform additional QC duties as assigned.
Required Qualifications (Must-Haves):
- Bachelor’s degree in Biological Sciences or related field.
- 2+ years of experience in a GMP QC laboratory or GMP/GLP environment.
- Hands-on experience with mammalian cell culture.
- Experience performing analytical assays such as ELISA, qPCR, flow cytometry, RNA sequencing, or similar technologies.
- Strong GMP documentation, data integrity, and compliant data recording skills.
- Ability to work independently, manage multiple testing assignments, and meet tight timelines.
Preferred Qualifications (Nice-to-Haves):
- Experience with cell-based or exosome-based products.
- Experience coordinating or managing samples with outsourced/contract testing labs.
- Knowledge of method qualification or validation requirements.
- Experience writing deviations, OOS investigations, or validation protocols.
- Experience with aseptic processing and work in classified environments.