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Document Issuance Specialist

Netherlands - HoofddorpQualityRegular

Job Description

We are seeking a highly motivated individual to join us as a Quality Systems - Document Issuance Specialist reporting to the Quality Systems Document Control Senior Manager. You will work in Quality Assurance team in supporting our efforts in this exciting new area of cancer immunotherapy. You will be responsible from preparing the batch specific document package for manufacturing operations and as well as issuance of other controlled documents. You will work closely with Manufacturing Planning to ensure readiness of documents timely and right first time.
 

Responsibilities (include but are not limited to):
The Quality Systems Document Issuance Specialist will use Kite’s Electronic Document Management System and enterprise resource planning (ERP) to issue controlled documents and labels.

Additional job duties include:

  • Responsible for the management of all document issuance and archival processes to support GMP operations.

  • Issue effective documents including procedures, test methods, specifications and batch documentation.; including final product labels.

  • Issue logbooks.

  • Ensure accuracy and completeness of QA issued documents.

  • Identify and escalate compliance gaps across the document management system

  • Execute strategic initiatives to improve the document management system.

  • Support investigation of deviations against the document management system and develop effective corrective action plans.

  • Support audits (internal, external)

  • Perform other duties as required to fulfill department and business needs.

  • Role requires shift availability during weekends.

Working location is Hoofddorp.  

Requirements:

  • 2+ years of relevant experience in a GMP environment related field and a BS or BA.

  • Prior experience in pharmaceutical industry, cell therapy, biologics, blood/human tissue, or vaccines experience preferred.

  • Demonstrates good interpersonal, verbal and written communication skills, which are essential in this collaborative work environment.

  • Working knowledge of electronic documentation systems, data retrieval, and electronic file formats.

  • Detail oriented with solid problem-solving acumen.

  • Ability to work effectively in a team environment.

  • Ability to analyse and reconcile moderately complex issues.

  • Must have demonstrated initiative and accountability in a fast-paced environment.

  • Proficient with computers and word processing software (i.e. Microsoft Office products).