Quality Assurance Specialist

4 weeks ago


Irvine, California, United States TCWGlobal Full time
Job Overview

Our client, a global leader in life science research and healthcare, is seeking a Quality Assurance Specialist to support the compilation and maintenance of IVDR technical files. The successful candidate will review and process labeling and FOC change requests, compile and create quality-related technical file documentations, and perform various quality tasks to support the QMS overall.

Key Responsibilities:

  • Review and approve labeling and FOC change requests
  • Compile and create quality-related technical file documentations
  • Perform various quality tasks, including LS FOC creation and non-labeling related change requests

Requirements:

  • Bachelor's degree in a relevant field
  • 2+ years of experience in Quality, Documentation Control, and Change Control processes in a GMP environment
  • Experience in compiling, reviewing, and updating quality-related technical file documentation
  • Basic understanding of GMP and quality system standards
  • Proficient in Microsoft Office
  • Detailed-oriented with the ability to multi-task

Please submit your resume for consideration.



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