Analyst, Quality Control, Microbiology

Overview

In this role you will support routine environmental monitoring and water sampling in a GMP facility, and contribute to microbiology testing for materials and products. You will be involved in method transfers, validations, and QA-related records, while collaborating with cross-functional teams to maintain cGMP standards. You drive precise execution of QC assays and contribute to audits and continuous improvement. This position offers hands-on microbiology work within Moderna’s mission to advance mRNA medicines.

Pay / Benefits

• Competitive healthcare benefits
• fitness, mindfulness, and mental health support
• family-building benefits (fertility, adoption, surrogacy)
• generous paid time off including vacation and holidays
• sabbatical and global recharge days
• discretionary year-end shutdown

Responsibilities

• Perform routine environmental monitoring and critical utility sampling
• Analyze water samples (TOC, Conductivity, Bioburden, Endotoxin)
• Execute GMP QC microbiology methods (Sterility, Bioburdn, Endotoxin) and related testing
• Support release, stability, and method/verification/validation samples
• Collaborate on method transfers with AS&T groups and external labs
• Contribute to development, implementation, and maintenance of lab systems (cGMP)
• Assist audit teams and prepare/ship/receive samples for microbiological testing
• Provide general lab support including reagent prep, equipment maintenance, housekeeping
• Participate in equipment/method qualifications, validations, and transfers
• Perform data entry with good documentation practices
• Support troubleshooting and mentor junior staff in data review and training
• Author quality systems records (EM excursions, investigations, deviations, CAPAs) and SOPs
• Promote a positive, collaborative culture and continuous improvement
• Follow all GxP regulations and internal policies; ensure data integrity and documentation readiness
• Complete required training and requalification plans

Key requirements

• BSc in a relevant scientific discipline with at least 2 years of QC experience in a cGMP organization (Microbiology)
• Hands-on microbiology testing experience (e.g., Vitek, Isolator Technology, Bioburden, BET, Sterility)
• Working knowledge of FDA, EU, ICH guidelines and GMP regulations
• Ability to collaborate in a dynamic cross-functional matrix environment
• Strong prioritization and multitasking abilities in a fast-paced setting
• Proven experience conducting investigations
• Note: enhanced pre-employment check may be required
• On-site role; not eligible for remote work

• collaboration in cross-functional teams
• attention to detail and data integrity
• investigative mindset for deviations and investigations
• Sterility testing
• Bioburden analysis
• Endotoxin testing

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