Sr. Specialist, Clinical Quality Assurance, Disposition
ModernaTX, Inc.

Norwood, Massachusetts

This job has expired.


The Role:
Moderna is seeking a Quality Assurance Senior Specialist/Specialist reporting to the Sr. Manager, Clinical Quality Assurance. The individual in this role will be responsible for GMP batch disposition for clinical products manufactured at Moderna. This individual will develop and execute based upon implemented quality systems / standards. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.

Here's What You'll Do:

  • Perform all activities required for batch disposition of Drug Product
  • Assess change controls for regulatory market restrictions
  • Prepare GMP documentation required for market release
  • Disposition clinical Drug Product to enable the fast-paced support of clinical trials
  • Execute required SAP transactions as necessary
  • Author and review SOPs and policies to ensure compliance and adherence to regulations and cGMP operations
  • Work closely with team members to recognize opportunities for improvement and help drive change
  • Participate on Process Improvement projects
  • Review manufacturing documentation including, but not limited to, electronic/paper batch records, EM data, etc.
  • Review and approve deviations, CAPA, change controls as needed
  • 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:
  • BS or equivalent and 3 - 5 years of experience, or a Master's level degree and 2 years' experience in the pharmaceutical/biotech industry

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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

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 committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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