Product data entry analyst/ sample handling support

Posted 13 days ago

integrated resourcesChesterfield (MO)

Data Entry Keyers Biological Product (except Diagnostic) Manufacturing

SENIORITY

Junior

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About the role

Product Data Entry Analyst/ Sample Handling Support 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.)QUALIFICATIONS AND SKILLS NEEDED:Background in biochemistry, biology, chemistry, or related scientific discipline; Understanding of normal pharmaceutical development processes Ability to work in a highly regulated environment and learn/comply with GMP expectations; Ability to accurately transcribe data from Excel documents to MS Word; Ability to thrive in a fast-paced environment and adapt to changing priorities; Familiar with Microsoft Office Suite, and computer literate enough to quickly learn new systems.

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