quality

Quality Assurance Document Control Specialist

As a Quality Assurance Document Control Specialist, you are a cornerstone in our mission to save lives. Together with your colleagues from the Document Control Team, you monitor the integrity of our documents. You manage the document lifecycle, from creation to archiving, ensuring quality and compliance.

What can you expect?

In our GMP-controlled environment, your expertise ensures the highest quality of cell therapy products. Your tasks and responsibilities include, but are not limited to:

  • Document management: You manage our document control systems, ensuring every process aligns seamlessly with our operational needs. Your oversight guarantees the smooth management of vital documentation throughout the site.
  • Review and compliance: You review new and revised procedures and documents to ensure they meet stringent global and site-specific standards. Your keen eye for detail ensures every document reflects our commitment to quality and compliance.
  • System support and management: You will increase user engagement with our Document Management System by providing the necessary support and guidance. You manage workflow processes efficiently so that each team member can apply them quickly and easily
  • Documentation issuance: You oversee the issuance of batch-related documentation, a cornerstone of our GMP manufacturing process. Your role is to ensure that every batch produced meets our high standards and regulatory requirements.
  • Document lifecycle management: You handle the reconciliation and archiving of GMP documentation, maintaining a meticulous record of our manufacturing journey. Your attention to detail ensures the integrity and accessibility of vital records for both current operations and future audits.

 

We work in a shift regime, no nights but weekends.

Who are we looking for?

We are looking for people who thrive in a GMP-regulated environment, and who are passionate about quality.

What do we offer?

About Legend Biotech

Legend Biotech is a global biotechnology company dedicated to developing, manufacturing and commercializing innovative and life-saving cell therapies, including treatments for hard-to-treat diseases like cancer.

Since our founding in 2014, we have expanded to over 2,000 employees across six global manufacturing facilities, with our headquarters in New Jersey.

In Ghent, we specialize in producing advanced CAR-T therapies for multiple myeloma, in partnership with Johnson & Johnson.

Want some additional information?

Don't hesitate to contact Annelies!

Annelies De Coninck

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