QA Specialist I

Job Description

We are seeking a highly motivated individual to join us as a Quality Systems - Document Issuance Associate reporting to QA Documentation lead 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.
 

Your new role
The Quality Systems Document Issuance Associate will use Kite’s Electronic Document Management System and enterprise resource planning (ERP) to issue controlled documents and labels.

Additional job duties include:

• 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.

• Support investigation of deviations against the document management system

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

• Role requires shift availability during weekends.

Working location is Hoofddorp.  

Requirements:

• 1+ years of relevant experience in a GMP environment related field and MBO/HBO

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

• 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.

• Ability to work effectively in a team environment.

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