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Specialist, Quality Systems and Compliance

Company: Moderna
Location: Bronx
Posted on: November 17, 2021

Job Description:

Modernas mission is to deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its:1st medicine having treated millions of peopleDiverse clinical portfolio of vaccines and therapeutics across 6 modalitiesA broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulationIntegrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speedMost recently, Modernas capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.Moderna is offering a 10K sign on bonus, relocation assistance, and great benefits.Responsibilities:Assist in improving and maintaining Modernas overall Quality Management System (QMS), including policies and procedures while keeping them current with emerging and changing regulations in the internal Quality Assurance department.Provide quality oversight from a compliance perspective for quality control laboratories, manufacturing and overall operations to deliver on early to late phase clinical programs at the Norwood cGMP manufacturing facility which includes raw material, plasmid, drug substance, formulation, drug product, finished goods and personalized medicine capabilities.Support Senior Level team members in managing the performance and effectiveness of the quality system programs such as change management, discrepancy and CAPA management, training, documentation and records management, and data integrity.Support team members in executing/assisting with the internal audit program and third party/regulatory inspection programs for the Norwood cGMP manufacturing facility.

Keywords: Moderna, New Rochelle , Specialist, Quality Systems and Compliance, Other , Bronx, New York

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