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Sr. Specialist, External CMO, Secondary (Baxter)

Moderna

Moderna is seeking a Sr. Specialist, Quality Assurance for a position based out of their Norwood, MA facility. The individual in this role will be responsible for providing Quality Assurance (QA) support for Moderna’s Drug Secondary packaging, labeling and distribution operations at External Contract Manufacturing Organizations (CMOs). The individual will primarily work with: Supply Chain Operations and logistics, Internal Quality Assurance and CMC as well as external Vendors including packaging, labeling, distribution and other related service providers to support packaging and labeling activities and outbound Supply Chain for Moderna. This individual will maintain quality oversight for packaging and labeling, perform batch record review and disposition, manage quality systems including change controls and deviations, monitor cold chain and temperature excursions amongst other key quality assurance activities. Additionally, the individual may manage data tracking systems to maintain metrics and trends. This role may also include supervisory responsibilities over some junior staff and contractors/consultants. The successful candidate must have experience in a biotech or pharmaceutical GMP environment.

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