Specialist, Data Reviewer, Quality Control Bioassay

ModernaTX • Norwood, MA

1d • $74,000 - $118,400 • Onsite

About The Position

The Role Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.” Moderna is strengthening its presence in Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide. In this individual contributor role, you will serve as a critical quality reviewer within QC Bioassay Laboratories, ensuring the accuracy, integrity, and timely release of data supporting molecular and cell based assays. You will combine technical depth, investigative rigor, and strong GxP discipline to maintain audit readiness and operational excellence across laboratory systems and documentation. Through mentorship, continuous improvement leadership, and digital enablement—including exposure to advanced analytics and generative AI driven tools—you will help strengthen QC performance and data reliability at scale. Here’s What You’ll Do:

Requirements

• BA/BS Degree Bachelors of Science (STEM degree) with minimum 5 years of experience in a cGMP laboratory, or a Master of Science (STEM degree) with minimum 3 years of experience in a cGMP laboratory and with hands-on experience in molecular biology, Cell based Assays and Protein Analysis.
• Previous experience reviewing data in GMP environment for GDP/GMP compliance as well as audit trail review

Nice To Haves

• Working knowledge of USP, ISO, FDA and ICH guidelines
• Familiarity with laboratory information systems
• Working knowledge of ALCOA principles

Responsibilities

• Review executed QC test records for molecular and cell based assays to ensure accuracy, compliance with Good Documentation Practices (GDPs), and adherence to Data Integrity requirements.
• Ensure documentation, data, and records are complete, accurate, and maintained in a state of inspection readiness to support business needs and regulatory audits.
• Understand and acquire knowledge to effectively navigate associated laboratory software systems and equipment interfaces, enabling thorough and technically sound record review.
• Review reagent and equipment logbooks to verify traceability, compliance, and operational consistency.
• Follow all relevant GxP regulations, guidelines, and company policies to ensure full compliance with regulatory and internal requirements.
• Execute tasks precisely as defined in internal guiding documents, including but not limited to SOPs and work instructions.
• Write and revise SOPs and reports to ensure clarity, technical accuracy, and regulatory alignment.
• Support internal and external audits, including audit preparation activities and direct support during inspections.
• Assist with audit preparation and broader regulatory compliance initiatives.
• Utilize strong investigative skills to identify, assess, and resolve issues within laboratory operations, driving effective root cause analysis and corrective actions.
• Assist with troubleshooting issues as applicable to ensure minimal disruption to laboratory operations.
• Lead and organize continuous improvement projects to enhance laboratory efficiency, documentation quality, compliance posture, and operational effectiveness.
• Work directly with management to ensure QC goals and milestones are met, proactively identifying risks and mitigation strategies.
• Perform on the job (OJT) training and act as a mentor to QC Bioassay staff, including mentoring and training junior team members.
• Foster a positive and inclusive work culture that promotes collaboration, innovation, accountability, and continuous improvement.
• Complete all required training and assigned learning plans according to defined due dates and prescribed requalification cadence.
• Embrace digital tools and opportunities to leverage advanced analytics and generative AI enabled solutions to enhance documentation review, trend analysis, deviation investigations, and overall laboratory performance.
• Perform additional duties as assigned in support of QC Bioassay operations.

Benefits

• Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level