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Specialist, Document Control and Record Management at Moderna Therapeutics in Burlington, Massachusetts

Posted in Other 30+ days ago.





Job Description:

The Role:
The Specialist role supporting Document Control and Records Management will be responsible for maintaining documents in compliance with business needs and regulatory expectations. This position will be mainly for the Burlington site, with some time being split in Norwood. The individual will be responsible for formatting and administration of paper-based and electronic document workflows, chain of custody, issuance, and archival of paper records as well as electronic document management and document certification. Excellent organizational skills, the ability to work independently on multiple tasks, and the ability to work in a fast-paced environment are required

Here's What You'll Do:


  • Support cross functional teams in processing document requests, document approvals, and document archival


  • Issuance and reconciliation of paper records (including batch records and logbooks)


  • Manage the archival of all GMP documentation, which is submitted to Records Management as well as to off-site storage


  • Implement process improvements for Document Control and Record Management Processes


  • Assist in document control process improvements with Document Types, Lifecycles, and Workflows in EDMS


  • Revise SOPs related to document control, document archival, and eDMS


  • Collaborate with cross-functional teams to identify efficiencies around maintenance/control of paper-based documents


  • Provide document control/records management support for internal/external audits and inspections


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


  • A minimum of two years of Quality Assurance experience in pharmaceutical industry providing Quality Assurance oversight with a BS degree; 0-2 years of experience with MS degree


  • Ability to translate complex issues into a meaningful set of recommendations


  • Demonstrated knowledge of cGMPs in a manufacturing environment


  • Strong independent judgement and decision-making abilities


  • Demonstrated problem detection and problem resolution skills


  • Must possess demonstrated organizational skills


  • Must possess excellent verbal and written communication skills


About Moderna:

In 10 years since its inception, Moderna has transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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