Irvine, CA

Quality Systems Specialist

Quality System Specialist

12-month position (potential to extend)

Irvine, CA

Pay: $32-$36/HR

Our client, a leading life science and research company is looking for a Quality System Specialist to join their team. This position will support the compilation and maintenance of IVDR technical files, review IVDR and other registration labeling change requests and various quality tasks to support the QMS overall.

How You’ll Make An Impact:

  • Review, approve, and process labeling and FOC change requests
  • Compile, create, review, and update quality related technical file documentations (i.e. DMR updates, compile finished product testing documents, etc)
  • Various quality tasks such as LS FOC creation, non-labeling related change requests, etc

What You Bring:

  • Education: Bachelors degree preferred or high school diploma/equivalent with 2 to 3+ years of work experience
  • Work Experience: 2+ years experience in Quality, Documentation Control, Change Control process, GMP
  • Basic understanding of GMP and quality system standards
  • Proficient in Microsoft office (word, excel, etc)

Please submit your resume in Word or PDF format to be considered.

  • Max. file size: 300 MB.