Dhvi data review specialist

Quality assurance (QA) for current good manufacturing practice (CGMP)-compliant programs is responsible for ensuring that components, intermediates, drug substance, and drug product are of the quality required for their intended use and that quality systems are maintained. With minimal management oversight and by working independently, the QA contractor will perform a variety of duties associated with the Office of Regulatory Affairs and Quality in support of the CGMP programs at client, including critical review of GMP analytical in-process, release, and stability data and critical review of deviations and investigations;. This position will consult with GMP analytical development staff, as applicable/requested, to serve as a resource. This position reports directly to the CGMP Program (DGP) Director of the Quality Systems Unit (QSU).