Associate I, Quality Control

The Role:

The Quality Control Associate l will perform routine environmental monitoring and water sampling of the GMP manufacturing facility. The Quality Control Associate l will also support microbiological testing for GMP QC raw materials, excipients, drug substance and finished product testing for mRNA products produced at Moderna’s manufacturing facility and affiliated contract organizations. The Quality Control Associate may perform projects as assigned.  This position is 1st shift, Wednesday-Saturday.  Off shift hours may be required.

Here’s What You’ll Do:

• Perform routine environmental monitoring and critical utility sampling activities

• Conduct analysis of water samples to include TOC, Conductivity, Bioburden, and Endotoxin

• Perform routine testing in support of manufacturing processes to include bioburden, sterility, endotoxin, culture purity and cell stock identity

• Prepare and ship contract laboratory testing samples including those intended for microbiological identification

• Perform general laboratory support activities including equipment maintenance and housekeeping

• May participate in equipment and method qualifications, validations, and method transfers

• Perform data entry utilizing good documentation practices

• Support initiation/closure of quality system records such as environmental monitoring excursion notifications and deviations

• Write/revise standard operating procedures

Here’s What You’ll Bring to the Table:

• BS in a relevant scientific discipline or 5 years Quality Control experience in a cGMP organization with a focus in Microbiology

• Familiarity with relevant and current FDA, EU, ICH guidelines and regulations

• Knowledge of GMP, microbiology, aseptic technique, and general laboratory instrumentation (preferred)

• Ability to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment

• Excellent communication skills (verbal and written)

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.

-