Our client is looking for Product data entry analyst/ sample handling support- with good Clinical Practices, Data entry, LIMS, GMP, Data transcription / verification, and LIMS sample review experience etc.
RESPONSIBILITIES:
• Data transcription, review, and trending of biologics (mAb, antibody drug conjugate, etc) stability data in preparation for regulatory filings.
• Specifically, the analyst will be expected to: Retrieve data from LIMS (Laboratory Information Management System) database or other data repository.
• Transcribe data into stability sections of regulatory filings, or perform 100% accuracy verification for previously transcribed data; Review sample results within LIMS to identify incomplete testing
• Notify Stability Lead of any unusual findings or gaps in data; Assist Stability Leads with various tasks as necessary
• Assist with sample handling duties as needed (shipment receipt, aliquoting, etc.)