Specialist, Quality Assurance (QA)

The Role:

ModernaTX, Inc. seeks a Specialist, Quality Assurance (QA) for its Norwood, Massachusetts location.

Here’s What You’ll Do:

• Participate in quality focused teams across Moderna’s broad ecosystem of functions.

• Oversee and review executed electronic and paper batch record documentation and work cross-functionally to drive corrective actions as needed.

• Execute and review disposition packages to perform Good Manufacturing Practices (GMP) release of drug product for clinical use.

• Enforce adherence to current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and manufacturing documentation.

• Utilize knowledge to improve operational efficiency and participate in continuous improvement projects.

• Write, update and revise procedures and work instructions.

• Monitor process operations to ensure compliance with regulatory requirements, policies and procedures.

• Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.

• Follow all relevant Good Practices (GxP) regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

Here’s What You’ll Bring to the Table:

Minimum requirements:

• Requires a Master’s degree in Project Management, Regulatory Affairs, or related field and 1 year of experience as a QA Associate, Quality Control (QC)/QA Specialist or related position supporting quality assurance operations for pharmaceutical manufacturing.

• 1 year of experience must include: 

  • Cross-functional project management;

  • Risk management and quality management for pharmaceutical products; 

  • Batch record reviews & product disposition workflows for pharmaceutical manufacturing;

  • Ensuring cGMP & Good Distribution Practices (GDP) compliance; and

  • Veeva, LIMS, & MODA quality control systems.

• May telecommute 2 days per month.

Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R17903) or email resume and cover letter to careers@modernatx.com with subject line: R17903.

#DNI

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 a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

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 mea