Associate II, Quality Assurance

The Role:
Moderna is seeking a Quality Assurance Specialist for a position based at their Norwood, MA manufacturing site and will directly support the growing area of Individualized Neoantigen Therapy (INT).  The main responsibility for this position is to provide batch record review and disposition of products to patients. Strong decision-making skills and independent thinking will be paramount for candidate success. The individual will work closely with Manufacturing and Quality teams.

This position is 2nd shift, Sunday – Wednesday or Wednesday – Saturday.

Here’s What You’ll Do:

• Review executed batch record documentation and perform batch disposition activities

• Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation

• Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review

• Perform review of environmental monitoring data

• Identifying risks and communicating gaps for quality and GMP process/systems

• Partner with manufacturing and support teams to initiate and triage new deviation events

• Support review and approval of deviations and CAPAs

• Support quality functional groups on as needed basis

• Authors and/or review SOPs, policies, and other GMP documentation to ensure compliance and adherence to regulations/cGMP operations

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

• Utilize knowledge to improve operational efficiency.

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

• 2-5 years of experience in a GMP biopharmaceutical GMP manufacturing environment

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• 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.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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 proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, co