Quality Assurance Specialist

Responsibilities

• Provide real-time quality oversight and on-the-floor support for Drug Substance and sterile Drug Product manufacturing
• Monitor process operations to ensure strict compliance with specifications and regulatory requirements
• Make critical quality decisions and escalate issues impacting operations or product quality
• Perform routine manufacturing suite walkthroughs to ensure GMP compliance and troubleshoot issues
• Enforce adherence to cGMPs, SOPs, and manufacturing documentation
• Partner with manufacturing and support teams to initiate, triage, and review deviation events
• Author and review essential documentation including SOPs, work instructions, and batch records
• Support continuous improvement initiatives to enhance operational efficiency and quality culture

Requirements

• Bachelor's degree in a science-related field (e.g., Biology, Microbiology, Chemistry, Pharmacy, or Engineering)
• 3–5 years of pharmaceutical or related experience in a GMP environment

Preferred Qualifications

• Experience in sterile drug product manufacturing
• Strong understanding of cGMP requirements and quality systems
• Proven ability to make independent decisions and escalate issues appropriately
• Strong cross-functional collaboration and communication skills
• High attention to detail with a focus on compliance and quality

Benefits

• Best-in-class healthcare and voluntary benefit programs
• Holistic well-being resources including fitness, mindfulness, and mental health support
• Family building benefits including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, bank holidays, and sabbatical
• Savings and investment opportunities to help plan for the future

About the Company

Moderna is pioneering the development of a new class of drugs made of messenger RNA (mRNA). We are building the leading mRNA technology platform and the infrastructure to reimagine how medicines are created and delivered. Our mission is to deliver on the promise of transformative mRNA science to bring new medicines to patients worldwide.