Specialist, Bioassay, Data Review

The Role

Moderna is seeking a Quality Control Data Review Specialist based at their Norwood, MA site. The individual in this role will focus on support of the QC Bioassay Lab with review of test records, management of QC Quality records (e.g. Change Controls, deviations, CAPA, Lab investigations, etc.), and author/update cGMP documents.

Here’s What You’ll Do

• Additional duties may be assigned
• Support authoring and revision of laboratory procedures and reports
• Review executed QC Bioassay test records for product release.
• Support team to investigate and resolve issues related to assay failures, system deficiencies, and equipment / assay troubleshooting.
• Work with QC group to maintain and update all necessary training documentation including On-The-Job Trainings, Training Materials, Instructor Led Training, and Knowledge Checks.
• Support authoring quality systems records such as deviations, change controls, CAPAs as required

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

• 5+ years of direct experience in GMP QC labs with experience in Bioassay methods. e.g. DNA Sequencing, Electrophoresis, PCR, Residual Protein Assays, and Cell Culture.
• BA or BS degree in Biology, Chemistry, or similar field

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
• Previous experience reviewing data for GDP/GMP compliance as well as audit trail review
• Previous experience managing quality records such as change controls, deviations, and lab investigations

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Volunteer time to participate within your community
• Dedicated care coordination support for our LGBTQ+ community
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Location-specific perks and extras!
• 401k match and Financial Planning tools
• Free parking or subsidized commuter passes
• Adoption and family-planning benefits
• Exclusive preferred pricing on Peloton fitness equipment
• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Generous paid time off, including:
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• Paid sabbatical after 5 years; every 3 years thereafter
• Discretionary year-end shutdown
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Vacation, sick time and holidays
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Free premium access to fitness, nutrition, and mindfulness classes

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 [email protected]. (EEO/AAP Employer)

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