||Performs operations necessary for quality testing and plays a role in implementing new technology within quality control. At more senior levels, provides an investigative or technological orientation in designing, executing, interpreting and validating quality procedures and test methods. Completes routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation. Aids in the development of test methods. Conducts data review and preliminary evaluation of results. Solves problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, etc. Provides input to the technical composition of operating documentation. Work is closely supervised. Follows standard practices to obtain solutions. Contributes to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group.
• Conduct routine testing for product release and stability functions as per written procedures in a compliant manner.
• Hands on experiance in Cell Based assays, Plaque Assays, ELISA , HPLC and spectrometric methods
• Experience in GMP envirnoment with ability to follow procedures in all aspects of lab activity and in good documentation practices
• Instrument and Assay troubleshooting
• Investigations of routine laboratory events such as OOS , OOT's ,deviations and CAPA's.
• Prior experience in Cell Based assays is highly desired.
• experience in a cGMP environment in a pharmaceutical or Medical Device required.