Quality Control Associate II/III, Analytical

The Quality Control Associate II/III, Analytical will perform analytical testing to support batch disposition, in process control, drug substance and drug product release, and stability studies. This role is central to ensuring product quality and regulatory compliance for Capricor’s cell based and exosome based therapeutic platforms. 

You will execute analytical assays, maintain mammalian cell cultures, document data in GMP compliant systems, support investigations, and collaborate cross functionally to ensure testing readiness and continuous improvement. This is a hands-on QC bench role within an expanding analytical team and a new headcount supporting pipeline and manufacturing scaleup. 

• Bachelor’s degree in Biological Sciences or related field. 

• 2+ years of experience in a GMP QC laboratory or GMP/GLP environment. 

• Handson 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. 

• 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.