9605 Medical Center Drive Rockville, MD 20850 US
• 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.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.