The Role :

Moderna is seeking a Quality Assurance specialist for a position based at their Burlington, 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 1st shift, Sunday Wednesday or Wednesday Saturday.

Heres What Youll 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 Modernas safety procedures and guidelines

Utilize knowledge to improve operational efficiency.

Heres What Youll Bring to the Table :

4 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, theinfrastructure 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 peopleare 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.

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, 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 an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.

com . (EEO / AAP Employer)

Last updated : 2024-03-05