About this role
Analyst, Quality Control, Microbiology
The Role
Reporting to the Manager, Microbiology, the Individual, will perform routine environmental monitoring (EM) and water sampling of the GMP manufacturing facility. The analyst will also support microbiological testing for GMP QC raw materials, excipients, drug substances, and drug product intermediates for mRNA products produced at Moderna’s manufacturing facility and affiliated contract organizations. This position will contribute to related method transfers and qualification activities. The QC Analyst may perform projects as assigned.
Here’s What You’ll Do
Perform routine environmental monitoring and critical utility sampling activities.
Conduct analysis of water samples to include TOC, Conductivity, Bioburden and Endotoxin.
Execute GMP QC Microbiology methods, focusing on Sterility testing, Bioburden analysis, Endotoxin, and other methodologies as needed.
Support testing for release, stability, and method and verification/validation samples.
Collaborate with AS&T groups on new methods transfers. Participate in method transfer projects for internal and external testing labs.
Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements
Provid