Quality Assurance Specialist jobs at Moderna - 333 jobs

The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. This role supports in-process and release testing for raw materials, drug substance, and mRNA drug products manufactured at Moderna's Norwood site and affiliated contract organizations. As a member of the QC Bioassay Lab, you will also be instrumental in ensuring that both short-term operational goals and long-term lab milestones are achieved. You'll play a key role in maintaining compliance, advancing testing capabilities, and driving continuous improvement. While this is a sole contributor position, you'll collaborate broadly, mentor team members, and even step in to represent management when needed. You will work hands-on with sequencing and qPCR methods, support both commercial and clinical product testing, and help operationalize new laboratory systems. This role offers a unique opportunity to be exposed to cutting-edge manufacturing and QC technologies-and to contribute to the future of biotech with direct proximity to GenAI-powered digital tools that are shaping how QC labs evolve. Here's What You'll Do Your key responsibilities will be: Execute in-process and release testing for raw materials, drug substances, and drug products in compliance with cGMP standards Generate high-quality testing data for clinical studies and approved commercial products Conduct technical assessments, manage deviations, and lead investigations impacting lab operations Support method transfers and method qualifications in collaboration with development teams Train colleagues through on-the-job (OJT) programs and act as a mentor to QC Bioassay staff Represent the QC Bioassay team in the absence of management Partner with QC leadership to ensure laboratory milestones and performance targets are met Lead or organize continuous improvement initiatives and cross-functional projects Troubleshoot assay performance, lab procedures, and equipment-related issues Your responsibilities will also include: Assist in scheduling, Tier meeting contributions, and QC resource coordination Maintain and qualify laboratory equipment in line with validation standards Write, revise, and maintain SOPs, technical protocols, and reports Support audit preparation activities and regulatory compliance processes Address CTU (Critical Temperature Unit) alarms and maintain system responsiveness Follow all relevant GxP regulations, SOPs, and work instructions meticulously Ensure adherence to Good Documentation Practices (GDP) and data integrity standards Complete training and requalification assignments per defined due dates The key Moderna Mindsets you'll need to succeed in the role: We obsess over learning. We don't have to be the smartest-we have to learn the fastest. You'll be working in a dynamic quality environment where continual adaptation, new testing methods, and tech-driven optimization are the norm. A growth mindset is essential to keep up with evolving expectations and support innovation in QC practices. We behave like owners. The solutions we're building go beyond any job description. This role will thrive with someone who takes full accountability-not only for their assigned assays and documentation but also for mentoring peers, troubleshooting proactively, and helping drive continuous improvements that elevate the lab's overall performance. Here's What You'll Need (Basic Qualifications) Education: BS in a relevant scientific discipline (Biochemistry) Experience: 5+ years of experience Demonstrated aptitude or ability to learn: Able gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards and guidance's. This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work. At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship. Here's What You'll Bring to the Table (Preferred Qualifications) A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between. 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 The salary range for this role is $74,000.00 - $118,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NB1 -