Specialist Data Reviewer Jobs

The Role:
Moderna is seeking a Quality Control Chemistry Specialist based at their Norwood laboratory, MA site. The individual in this role will review data generated by Chemistry associates in support of the Release of Personalized Cancer vaccine program product lots. This role may support special projects as needed. This position will be 12-h Day Shift.
Here’s What You’ll Do:
Performs routine analytical chemistry data review and reporting of data generated through the laboratory tests including HPLC/ UPLC, GC, UV, Particle Analysis and Dynamic Light Scattering, Osmolality, pH, Appearance, 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 Chemistry 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
Here’s What You’ll Bring to the Table:
Minimum education required: Bachelor’s degree in a relevant scientific discipline, preferred in Chemistry
Minimum experience required: 2-5 years in a laboratory setting with focus in pharmaceutical QC analytical chemistry
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:

• Volunteer time to participate within your community
• Vacation, sick time and holidays
• Paid sabbatical after 5 years; every 3 years thereafter
• D iscretionary year-end shutdown

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. #LI-AW1
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