Quality Assurance Specialist
The Quality Assurance Specialist will assist with the oversight of all activities occurring at contract manufacturing organizations (CMO) including batch record review, change controls, deviations, CAPAs, process qualifications and risk assessments. This position will support the Medexus Manufacturing Science and Technology (MSAT), Quality Control and Regulatory teams with data trending, analysis and reporting. They will ensure that manufacturing records are qualified/validated per cGMP and that all QA activities are conducted in accordance with FDA regulatory requirements to ensure ongoing supply of product to meet clinical and commercial demand. For complete job description click here
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