Iris Wu

Master's

Biomedical Science

Vaccine Science Department

Quality Assurance Auditor III Thermo Fisher Scientific

- Serves as QA lead overseeing 4 ELISpot programs to meet client deliverables - Identifies issues impacting quality and collaboratively develops resolutions and risk management strategies - Attends internal meetings and client meetings to build strong relationships with key shareholders - Collaborates with initiative leads to develop, optimize and improve processes to increase efficiency - Reviews and revises standard operation procedures (SOPs) and audit plan - Delivers training to Richmond, VA and Suzhou, China QA staff - Managed and provided direct oversight to team of 2 QA staff members - Quality Assurance Auditor II, Pharmaceutical Product Development, Inc., Vaccine Science Department - Richmond, VA - Conducted complex internal audits to ensure laboratory, client standards and GxP regulatory guidelines were met - Completed internal facility audits to maintain readiness for FDA inspections - Created training material for newly hired QA staff - Performed technical document review related to lab functions and procedures for R&D studies and Phase I-IV clinical trials - Reviewed deviations, root cause analysis, CAPAs, and change controls in Veeva QMS - Senior Scientist, Pharmaceutical Product Development, Inc., Vaccine Science Department - Lead scheduler overseeing 5 MOPA programs - Responsible for planning/assigning assays and schedule updates for 52 analysts in order to maintain clinical deadlines - Handle the batching of multiple clinical and R&D samples - Communicate with project PIs for any scheduling changes/conflicts - Previously led the ordering/inventory team to ensure that the supplies were ordered/received in a timely manner and that the quantity met throughput needs - Helped with the start up for SMOPA, completed several OJT for reagent prep/ assay procedures for newly hired analysts - Scientist, Pharmaceutical Product Development, Inc., Vaccine Science Department - Perform multiplex opsonophagocytosis assay (MOPA) to determine the clinical efficacy of pneumococcal vaccines - Operate CTL ImmunoSpot - Analyzer to image growth of microcolonies - Responsible for the purchase and maintenance of inventory stock - Perform data and electronic bench sheets QC review - Proficient with the use of eSheet, ShelfLife, ConneXion, Assist and ECM - Train others in assay procedures as needed - Cross-trained on HL60 cell harvest - Perform routine maintenance and calibrations of instrumentation according to SOP's - Research Analyst, Medical Science & Computing, contractor for NVITAL-Vaccine Research Center, NIAID/ NIH - Performed clinical phase I/II studies to evaluate the immunogenicity of Ebola, HIV, Malaria and Influenza vaccines - Performed flow cytometry based intracellular cytokine staining (ICS) assay to measure T cell mediated immune responses - Nov. 2019- Jun. 2021 - Mar. 2018- Oct. 2019 - Nov. 2015- Mar. 2018 - Gaithersburg, MD