Quality System Documentation Specialist ( Manufacturing)

Irvine, CA (*Local candidates only)

$32-36hr ( Weekly pay + Benefits)

1 year contract ( Excellent potential for permanent or extension)

Full-time: M-F 8am-5pm. (Hybrid. 3 days onsite)

Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities all over the world. Together they are helping people everywhere live longer, healthier lives!

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
• 2+ years of experience in Quality, Documentation Control, Change Control process in a GMP
• Experience to compile, review, and update quality related technical file documentation
• Basic understanding of GMP (Good Manufacturing Practices) and quality system standards
• Proficient in Microsoft office (word, excel, etc)
• Detailed oriented with the ability to multi-task

Please send your resume. Thank you!