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Data Review Specialist
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Full-time
- As the Data Review Specialist, you will be responsible to independently provide analytical of data generated for all internal and external customers of the Laboratory Operations group in Exton.
- Perform cGMP Data Review on the analytical data generated in Lab Operations which may include raw materials and finished goods, product performance, container closure integrity, leachables/extractables, particle analysis, stability, and/or microscopy/investigation.
- Review various techniques available in the laboratory including but not limited to CCI testing, chromatography including mass spectrometry, USP/EP/JP/YBB Compendia Testing, ISO Testing, Instron and Zwick, ICP, ICPMS, DSC, TGA, IR, UV, AA.
- Review the analytical raw data generated by first and second shift laboratory operations according to established methods, protocols, Compendia and Work Instructions for cGMP compliance.
- Review Electronic Data and Audit Trails for Data Integrity compliance.
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