Specialist, Quality Control, Data Reviewer REDA

The Role:
Moderna is seeking a Quality Control Specialist based at their Norwood laboratory, MA site. The individual in this role will review data generated by Bioassay associates in support of the Release of individual Neoantigen Therapy program product lots. This role may support special projects as needed. This position will be 10-h Day Shift. (Sun-Wed)

Heres What Youll Do:

• Performs routine data review and reporting of data generated through the laboratory tests including Cell based potency assay (REDA), Residual host protein, DNA sanger sequencing, Plasmid Identity, etc.

• Perform data review in LIMS and in paper worksheets if applicable.

• Ensure all laboratory tests are performed correctly and meet cGMP and GDP compliance requirements.

• Communicate the OOS/OOT/OOE/LE/Deviation cases to quality event investigation team promptly to ensure the Bioassay lab comply with investigation/deviation SOP procedures. Support the Support the investigation activities. Follow up and follow through the investigation closure to approve the final data in LIMS.

• Ensures timely and successful execution of the assigned data review and data management task.

• Interact with other analysts when corrections are identified as part of the data review process.

• Supports Troubleshooting of methods and equipment.

• Performs data entry and supports trending and analysis as applicable.

• Perform and/or support Certificate of Analysis generation as needed.

• Participates in project meetings to provide status updates to stakeholders

• Provides prompt communication of risk and mitigation for all data management related deliverables.

• Assist in regulatory, customer and internal quality audits that involve data review and data management.

• Assist in test scheduling as necessary (e.g., when tests needs to be repeated based on data review) to meet the project timelines.

• Work on continuous improvement for data review requirements and processes to ensure delivery of highest quality of data

• Complete and maintain cGMP documentation (electronic and Hard Copy) for laboratory raw data packets.

• Support authoring quality systems records such as deviations, change controls, CAPAs, OOS/OOT/OOE/LE, etc.

• Establish and maintain a safe working environment

Heres What Youll Bring to the Table:

• Minimum education required: Bachelors degree in a relevant scientific discipline, preferred in Biology or Biochemistry

• Minimum experience required: 2-5 years in a laboratory setting with focus in pharmaceutical QC

• Strong attention to detail

• Effective communication skills

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

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

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. Were 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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