Nadia Hani

Background

About Nadia Hani

I am currently working as an Expert Quality Assurance Specialist (GMP/GCP) in mRNA Cell Therapy at Cartesian Therapeutics, Inc. Some of my responsibilities include pre-line clearances, in-process auditing in a cleanroom, implementing QMS (MasterControl and iGMP), raw material release, batch record review, writing SOPs, non-conformances, change controls, deviations and CAPAs. I also work on process improvements and streamlining quality systems (i.e. Deviations, OOS and CAPAs). In my past, I have worked in GLP, regulatory affairs (FDA rules/regulations), medical devices, drug substances (pharmaceuticals), GMP, cell therapy and GCP. I have seven years of industry experience in quality (both quality control and quality assurance). Along with my work experience, I have my masters in Biomedical Science, so I have ample laboratory experience with assays such as PCR, gel electrophoresis, flow cytometry, and ELISA, etc. My interests include Cell Therapy, Quality Control/Quality Assurance, R&D, Project Management, MSAT, Biomedical Engineering, and Regulatory Affairs.