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Quality Documentation Specialist

Netherlands - HoofddorpQualityRegular

Job Description

Quality Documentation Associate

Job Description

Kite, a Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

  • Responsible for verification of controlled issued batch document and label packages including Final product labels per cGMP, as requested by operational departments.
  • Responsible for verification of controlled issued logbooks.
  • Provides hands-on day-to-day guidance to the personnel
  • Responsible from timely consumption of consumables/GMP materials used or informing the responsible person.
  • Responsible from maintenance of materials inventory.
  • Ensure accuracy and completeness of QA issued documents.
  • Identify and escalate compliance gaps across the controlled issuance process.
  • Propose/Execute strategic initiatives to improve the controlled issuance process.
  • Support/ investigate deviations on controlled issuance process and develop effective corrective action plans.
  • Support Audits (internal, external)
  • Additional duties as assigned.

 

Experience and Skill requirements 

  • Demonstrates advanced technical knowledge GMP
  • Demonstrates the ability to clearly and concisely present/ explain document issuance operation and its requirements /guidelines to multiple internal audiences.
  • Demonstrates ability to cross train colleagues and customers..
  • Demonstrates an ability to communicate effectively with stakeholders, senior colleagues and peers
  • Demonstrates the ability to think outside of the process and consider the impact decisions will have on other areas.
  • 2+ years GMP experience
  • Advanced level of English communication