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Dallas/Fort Worth Area United States

Quality Assurance Specialist

Medical / Health Care / Pharmaceuticals

Audit of manufacturing and laboratory records to ensure compliance to GMPs, GDP and company procedures. Administration of quality event systems for issuance, tracking and coordination to ensure timely completion. Coordinate issuance, tracking and release of manufacturing quality assurance holds of material and product. Provide quality assurance support of site engineering studies and validation activities and quality review of supporting data to ensure compliance with governing protocols, GMPs, good documentation practices and company procedures. Assist and provide input as part of a project team to resolve quality and manufacturing issues and identify and implement corrective and pre...