Specialist, Quality Assurance

Moderna; Norwood (MA); On-site; USD 65,000 - 80,000; Full time

Job summary

Moderna is seeking a Specialist in Quality Assurance to provide on-the-floor support in manufacturing at their Norwood facility. The candidate will be responsible for quality compliance, troubleshooting, and supporting quality decisions impacting operations. A Bachelor’s degree and relevant experience are required.

Benefits

Best-in-class healthcare coverage

Holistic well-being support

Family planning and adoption benefits

Generous paid time off

Savings and investment opportunities

Qualifications

• Minimum Bachelor's degree in a relevant field.
• 3 years experience in Quality Control.
• Familiarity with GMP regulations and technical documentation.

Responsibilities

• Support manufacturing activities and troubleshoot equipment.
• Review and approve quality systems records (SOPs, investigations).
• Collaborate with Manufacturing and support internal audits.

Skills

Quality Control

GMP Regulations

Technical Writing

Root Cause Analysis

Visual Inspections

SAP

Education

Bachelor’s degree in Chemistry, Biology, Materials Science and Engineering, or related field

Job description

The Role:

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

Here’s What You’ll Do:

• Provide quality on-the-floor support of manufacturing, reviewing documentation, and

• providing real-time support of manufacturing issues and change overs.

• Assist with troubleshooting equipment.

• Participate, support, review, and approve the authoring of quality systems records such as investigation, deviations, change controls, Corrective and Preventative Actions (CAPAs) and Stability program support.

• Support quality decisions that may impact operations, ensuring appropriate escalation.

• Review data entry and support Stability trending data.

• Collaborate with Manufacturing to support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping, managing and stocking of materials and supplies, and establishing and maintaining a safe laboratory working environment.

• Review and approve facility work order request and return-to-service documentation.

• Support internal audits and practice safe work habits and adhere to Moderna’s safety procedures and guidelines.

• Author and review Standard Operating Procedures (SOPs), policies, protocols, and reports to ensure compliance and adherence to regulations and current Good Manufacturing Practices (cGMP) operations.

• Complete and maintain cGMP documentation for work performed.

• Identify risks and communicate gaps for quality and GMP process and systems.

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

• Minimum requirements:

• Requires a minimum of a Bachelor’s degree, or foreign equivalent, in Chemistry, Biology, Materials Science and Engineering, or related field and 3 years of experience as a Quality Control Chemist, Quality Control Scientist, or related position involving quality control.

• Must have 3 years of experience with:

• Conducting visual inspections in pharmaceutical manufacturing;

• GMP regulations;

• Technical writing to document investigations and SOPs;

• Root cause analysis for investigations & deviations; and

• SAP to manage and track quality processes.

Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R17846) or email resume and cover letter to [e-mail] with subject line: R17846.

#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 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 [e-mail] .

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.

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