Stability Specialist, Global Quality Services
Current• Stability sample management, including the logging in of new samples, storing samples in environment chamber and/or Stability Room, coordinating monthly sample pull for testing and distribution of samples amongst the Quality Control Laboratory network and disposing samples when stability testing is completed. • Maintaining all original documentation related to Stability Program, including creating study folder for each new sample received, generating test forms for monthly sample pull, filing all original test forms and any associated documentation in study folder, trans filing of all completed study folders in accordance with the Company’s document retention Standard Operating Procedures.• Initiating new stability studies utilizing the SLIM application, including reviewing study test forms for trending of results and completeness, identifying OOS/OOT test results and subsequent investigation follow up, entering, verifying and approving study test forms.• Generating Stability reports upon request for Domestic Brand Requirements, International Registrations, Internal and External Audits, Product Development, R&D and Technical Services.