||• 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.
• 6 to 9 years.
• 2-4 years related experience in a cGMP environment in a pharmaceutical or Medical Device required.
• 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.
• Documentation, Medical Device , Quality Control , Analytical Chemistry, Biochemistry
• CGMP, Chemistry , ELISA, GMP, HPLC, Laboratory , Operations Solutions , SOPS, Testing
BS in Analytical Chemistry/Biochemistry or Biology. Prior experience in Cell Based assays is highly desired.