Perform QA Shop floor activities.
- Developed and maintained quality assurance protocols, processes, and procedures.
- Conducted regular internal audits to identify non-conforming issues.
- Analyzed data from inspection results for trends in order to recommend process improvements.
- Maintained knowledge of current industry developments and regulatory requirements for quality assurance purposes.
- Monitored production operations for conformance to established quality standards.
- Monitored CAR-T cell therapy procedures and activities in the aseptic shop floor in accordance with GMP and FDA regulations and procedures, including Bulk Media, PBMC Isolation and wash, Cell Initiation, Lentiviral transduction, gravity draining, static process as well as LOVO Drug Product Harvest procedures.
- Performed line-clearance procedures and verification of performed cleaning for a workstation (pre and post-decontamination)
- Verified Bio Safety Cabinet (BSC) procedures for the Lentiviral Transduction process, environmental monitoring, multi-sizer count (e.g. cell concentration, cell volume percentage),
- Verified Drug Product labels for final packaging before cryo-preservation storage (before moving drug product cassettes with the cold packs to the CRF, to ensure that the vials and drug cassettes and the cryo box are labeled with the proper information prior to placing them in the CRF)
- Verified all documentation is present during receiving of apheresis, such as the Certificate of Conformance or Mononuclear Cells (MNC) Collection Procedure Record, apheresis receipt according to Global Apheresis Specification
- Established communication between various departments using MS&T Leadership Team’s support during shop floor activities
- Reviewed test methods, qualification protocols and reports using online databases such as Veeva, Compliance Wire and eQRMS.