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QA Specialist

Rockville, MD 20850

Posted: 08/18/2022 Employment Type: Contract Job Category: Quality and Compliance Job Number: 482214 Country: United States Is job remote?: No

Job Description

• Assist in reviewing the documents, including manufacturing Production Records, testing record, and validation protocols and reports
• Assist in compiling and verifying all batch related documents into a Final Product lot disposition package
• Perform quality investigations of manufacturing Deviations, GMP and Quality System issues, non-conforming materials, and CAPA
• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues
• Participate in the management of day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities
• Review equipment and facility technical and investigation reports
• Assist in reviewing proposed changes to systems, procedures, methods, and submissions to regulatory agencies
• Perform other duties as required
*Previous Cell/Gene Therapy experience preferred. 
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