Diati Staffing
Quality Control Analyst
Diati Staffing, Gaithersburg, Maryland, United States, 20877
The Quality Control Senior Analyst is responsible for day to day operations related to release and stability testing, maintaining QC cell culture lines, and writing SOPs, deviations, change controls and CAPAs as part of typical QC operations.
Responsibilities include but are not limited toPerforms GMP release and stability testing in Quality ControlWrite technical reports and supporting documentation such as deviation, reports, testing protocols, and trend analysesReview of laboratory notebooks, protocols and reportsPerform day to day activities for cell propagation used for QC release and stability assays.Participate in technology transfer, method qualification and validationLeading the lab in 5S and routine housekeeping activitiesMaintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development
Minimum requirementsMinimum of a Bachelor's degree or equivalent in a scientific disciplineMinimum 8 years of industry experience in a cGMP laboratory, preferably related to biopharmaceutical industry operationsHands on experience performing ELISA in a cGMP environmentHands on experience performing SDS-PAGE in a cGMP environmentWorking knowledge of Sf9 Insect Cell Culture Procedures and cell-based assays e.g. HS plaque and Rapid Titer assayGxP (regulatory relevant skills and knowledge) GLP/GCP/GMP requiredJob holder should be a good understanding of relevant regulatory/industry standards and requirements
Responsibilities include but are not limited toPerforms GMP release and stability testing in Quality ControlWrite technical reports and supporting documentation such as deviation, reports, testing protocols, and trend analysesReview of laboratory notebooks, protocols and reportsPerform day to day activities for cell propagation used for QC release and stability assays.Participate in technology transfer, method qualification and validationLeading the lab in 5S and routine housekeeping activitiesMaintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development
Minimum requirementsMinimum of a Bachelor's degree or equivalent in a scientific disciplineMinimum 8 years of industry experience in a cGMP laboratory, preferably related to biopharmaceutical industry operationsHands on experience performing ELISA in a cGMP environmentHands on experience performing SDS-PAGE in a cGMP environmentWorking knowledge of Sf9 Insect Cell Culture Procedures and cell-based assays e.g. HS plaque and Rapid Titer assayGxP (regulatory relevant skills and knowledge) GLP/GCP/GMP requiredJob holder should be a good understanding of relevant regulatory/industry standards and requirements