Specialist, QA - On the Floor
ModernaTX, Inc.

The Role:

Moderna is seeking a Quality Assurance Specialist responsible for real time on the floor quality oversight of clinical manufacturing of clinical products and lot disposition at Moderna Inc. This position will be based on our Clinical Manufacturing sites at Burlington. The individual in this role will be part of a cohesive team responsible for supporting Clinical cGMP cell bank, plasmid, and mRNA drug substance produced at Moderna. They will provide real time quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight of manufacturing as well as experience in clinical manufacturing. Strong decision-making skills and independent thinking will be paramount for candidate success. They will interact fluidly with peers and supervisors in Quality, as well as cross-functionally with Manufacturing and other supporting functions.

Shift: 2nd shift (3:00pm - 1:00am) - Wed-Sat

Here's What You'll Do:

• Provide on-the-floor Quality support to manufacturing, review documentation, and make quality decisions and/or escalate issues to management that may impact operations.
  
• Perform routine walkthroughs of the manufacturing suites partnering with manufacturing on suite maintenance, Quality best practice implementation and troubleshooting when problems arise.
  
• Participate in quality oversight of manufacturing through real-time observations of activities.
  
• Monitor process operations to ensure compliance with specifications.
  
• Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review.
  
• Identifying risks and communicating gaps for quality and GMP process/systems
  
• Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
  
• Partners with manufacturing and support teams to initiate and triage new deviation events, reviews minor manufacturing deviations.
  
• Oversee and review executed electronic and paper batch record documentation.
  
• Support quality functional groups on as needed basis.
  
• Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations.
  
• Perform lot disposition of Cell Bank, Plasmid, and Drug Substance
  
• 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:

• A minimum of 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 Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

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. We're 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)

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