Quality Assurance Specialist

4 days ago


Irvine, California, United States Yoh Full time
Job Title: Quality Systems Specialist

Job Summary:

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.

Responsibilities:
  • 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.
Requirements:
  • Basic understanding of GMP and quality system standards
  • Proficient in Microsoft Office (Word, Excel, etc.)
  • Detailed-oriented with the ability to multi-task
What We Offer:
  • Medical, Dental & Vision Benefits
  • 401K Retirement Saving Plan
  • Life & Disability Insurance
  • Direct Deposit & weekly ePayroll
  • Employee Discount Programs
  • Referral Bonus Programs

Estimated Pay Range: $25.20 - $36.00 per hour

Yoh is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.



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