Quality Control Analyst Ii
Current• QC testing of final drug product and stability samples following established test method (SOPs)• Performing assays for drug product samples including appearance assays for visible particles and degree of colouration, osmolality, and container closure integrity tests.• Carrying out HSV ELISA for drug product, drug substance and expression samples.• Working with genetically modified HSV strain• Reviewing testing data and documentation of other QC operators• Preparing and assisting in the qualification of new assay controls• Receiving temperature-controlled samples from international lab locations, confirming suitable shipping conditions and contents• Initiating and completing investigations for deviations from procedures involving product impact and root cause analysis• Liaising between QC and facilities department and leading weekly tracking meetings to ensure routine equipment maintenance is carried out to schedule with minimal impact to laboratory testing• Communicating with external vendors to ensure equipment service is completed as required and appropriate documentation received
