Anna Toscano, Ms Email and Phone Number

Acquired by Merck

• Perform in-process testing to support manufacturing including bioburden testing, microscopic evaluation and endotoxin LAL.• Perform raw material release testing including nitrogen, carbon dioxide and oxygen identity testing, pH, appearance, reconstitution time, osmolality and FTIR testing.• Manage the environmental monitoring program and environmental monitoring contractors.• Perform environmental monitoring including viable air sampling, non-viable air sampling, surface sampling and plate counting.• Generate Certificate of Analysis/Certificate of Testing for release of drug substance/drug product.• Support manufacturing processes including process/personnel monitoring and removal of cells from the cryofreezer for thaw.• Perform sample log in for all samples provided by manufacturing including in process and drug substance samples.• Execute QC review of documents.

• Execute aseptic gowning technique to perform Environmental Monitoring within an ISO 5, ISO 7 & ISO 8 class Environment. • Perform environmental monitoring including viable air sampling, non-viable air sampling, surface sampling, water sampling, and compressed air system sampling.• Technical review of raw laboratory data.• Utilize and reference SOPs in order to maintain cGMP/GxP compliance.• Correspond with client contacts regarding sampling plans, sampling excursions and scheduling.• Initiate and execute NCMRs and CAPAs.