Co-op, Document Control

2 weeks ago

Waltham, United States ElevateBio Full time

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

ElevateBio is looking for a highly motivated and well-organized professional to join the Quality Systems team working in document control and records management. This individual will work closely with the Training, Quality Operations and Digital Quality teams, as well as across cross-functionally with Supply Chain, Manufacturing, Technical Operations and Quality Control teams.

Here's What You'll Do:

  • Collect, organize, and migrate data and existing legacy records into validated electronic repositories.
  • Issue controlled copies of logbooks to area departments.
  • Support the tracking, reconciliation, and archiving of physical and electronic records in compliance with retention procedures and requirements.
  • Assist Document Control in formatting, reviews, and approvals.
  • Assist in delivering the Quality Docs full user training and user support.
  • Support attendance request notifications for weekly Deviation, CAPA, and Change Control meetings.
Requirements:
  • Strong knowledge of Microsoft Office, including Word, Excel; Knowledge of SharePoint a plus.
  • Strong written and verbal communication skills.
  • Ability to work well with a small team in a fast-paced environment.


Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision:
We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.

ElevateBio 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. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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