Sr. Specialist, Quality Assurance, 1st Shift Wed-Sat

The Role

Moderna is seeking a Quality Assurance Sr Specialist for support and oversight of internal Clinical manufacturing at Moderna Inc. This position will be based in our cGMP Manufacturing site in Norwood, MA. 

The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug products produced internally at Moderna.  He/she will provide 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 or manufacturing experience in early-stage clinical products.  They will be able to interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Manufacturing, Logistical and Process Development Technology Transfer counterparts.

Here’s What You’ll Do

• Closely partner with peers for disposition of Plasmid, Drug Substance and Drug Product

• Participate in quality focused teams across Moderna’s broad ecosystem of functions.

• Authors and reviews SOPs, policies, and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.

• Oversee and review executed electronic and paper batch record documentation.

• Develop batch records, SOPs and training materials for startup of the Norwood Facility

• Reviews minor manufacturing deviations.

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

• 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.

• Monitor process operations to ensure compliance with specifications.

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

• Utilize knowledge to improve operational efficiency.

• Participate in quality oversite of manufacturing through real-time observations of activities.

• Additional duties as may be assigned from time to time

Here’s What You’ll Need (Minimum Qualifications)

• Bachelor’s Degree

• At least 6 years of experience

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 winter shut down 
  •    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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