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Associate II, QC Microbiology

Norwood, Massachusetts, US
Closing date
Jan 26, 2022

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Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
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POSITION DESCRIPTION Title: Associate II, QC MicrobiologyLocation: Norwood, MAReports to: Supervisor, QC Microbiology The Role:Reporting to the Supervisor of QC Microbiology, the Quality Control Associate II will support microbiological testing for GMP QC raw materials, excipients, drug substance and finished product testing for mRNA products produced at Moderna's manufacturing facility and affiliated contract organizations. He/she may also support environmental and critical utility monitoring activities. Here's What You'll Do:
Perform microbiological testing to include but not limited to the following: Culture Purity and Cell Stock Identity, Cell Density Determination, TOC and Conductivity Testing, Endotoxin, Sterility, Bioburden, Biological Indicator Analysis, Growth Promotion Testing, Microbial Identification using Vitek Maldi-TOF.PerformE. coli cell bank testingPerform environmental and critical utility testing.Support testing for raw materials, intermediates, drug substance and drug product, including generation of testing data to support clinical studiesAssist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirementsMay assist with equipment qualification / validation activities, including maintenance May troubleshoot issues related to equipment, laboratory procedures and assay performanceWrite/revise SOPs, technical protocols and reportsOffer input and suggestions for improvement in laboratory operations and proceduresTrain and provide technical guidance to other microbiologistsHere's What You'll Bring to the Table:BS in a relevant scientific discipline with at least 2 years relevant Quality Control experience in a cGMP organization with a focus in MicrobiologyFamiliarity with relevant and current FDA, EU, USP, ICH guidelines and regulationsExperience in the execution of kinetic chromogenic endotoxin analysis, Sterility, Bioburden, and Growth Promotion TestingExperience in testing cell lines
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