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QC Associate

Summary:To perform QC analytical testing in support of biologics bulk drug substance manufacturing using defined methods in a cGMP compliant laboratory. Assures test results are accurately recorded and abnormal data or equipment/instrument malfunctions are promptly reported to his/her supervisorResponsibilities:Performs routine testing and data review of batch release and stability samples of Bulk Drug Substance in a cGMP compliant environment.Performs routine assays such as UV-VIS Spectrometry, SDS Page and various HPLC methodologies, (e.g. SEC and reverse phase).Performs sample management including: sample receipt, sample tracking, aliquots preparation, and sample distribution.Aids in troubleshooting equipment and methods.Qualifications:Knowledge of science generally attained through studies resulting in a B.S. in chemical sciences, a related discipline, or its equivalent is required.Knowledge of laboratory techniques such as pH, volumetric measurement and basic laboratory safety practices.Some understanding of regulatory standards.Some relevant experience in a biologics QC lab preferred.

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