Specialist, Quality Assurance (QA for QA/FAC)

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 Individualized Neoantigen Therapy (INT) unit.The main responsibility for this position is to provide quality oversight of Quality Control and Facilities, with a focus on deviations, change controls, and CAPAs. The individual will work closely with Manufacturing, Quality Control, and Facility teams.
This position is our 2nd shift (2PM - 12AM) Wednesday - Saturday.
Heres What Youll Do:

• Identifies, classifies, and reports deviations, as appropriate, and typically works on more complex minor and/or major deviations.
• Responsible for providing quality oversight to the change management system for change controls. This includes providing plan creation oversight, verifying that changes adhere to SOPs and regulatory compliance.
• Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone.
• Works closely with others to determine root cause and potential preventative/correction actions.
• Authors and reviews SOPs and policies. Create and establish process and procedures to ensure compliance and adherence to regulations and cGMP operations.
• Ensure timely closure of investigation.
• Participates in quality oversight of Quality Control and Facilities.
• Reviews and approves facility alarms, facility work requests, and return-to-service documentation.
• Reviews and approves QC method qualification protocols and reports.
• Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems.
• Participate in internal audits for compliance with SOPs, GMPs, and regulations.
• Other activities as deemed necessary e.g. logbook reviews

Heres What Youll Bring to the Table:

• 3-5+ years' experience in a GMP manufacturing environment with a bachelor's degree in Biology, Chemistry, Chemical Engineering, Biomechanical Engineering, Bioengineering, Biomedical Engineering, Biochemistry, or related field

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 ModernaSince 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.
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, 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)-