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
• Provide support to audit teams for internal and vendor audits
• Prepare and ship/receive contract laboratory testing samples including those intended for microbiological identification
• Perform general laboratory support activities including reagent preparation, equipment maintenance and housekeeping.
• May participate in equipment and method qualifications, validations, and method transfers
• Perform data entry utilizing good documentation practices
• May assist with troubleshooting assay methods and equipment. Supports more junior staff with data review, training, and troubleshooting.
• Participate in authoring quality systems records such as EM excursions, investigation, deviations, change controls, CAPAs; Write/revise SOPs, protocols, and reports.
• Foster a positive and inclusive work culture that promotes collaboration, innovation and continuous improvement.
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.