Senior Quality Assurance Specialist

19 hours ago


North Chicago, Illinois, United States Collabera Full time
Job Overview

We are seeking a Senior Quality Assurance Specialist to join our team at Collabera, a global digital solutions company. This role will be based in Austin, Texas or North Chicago, Illinois.

Estimated Salary: $27/hr - $31/hr

Responsibilities

The ideal candidate will have knowledge of global regulatory requirements for pharmaceutical, medical devices, and combination products. They will be responsible for assuring complaint records meet global requirements, product complaint documentation, investigation, and review of all non-medical complaint content.

  • Ensure complaint documentation meets Good Documentation Practices as well as GMP and GCP.
  • Identification of potentially reportable events and notification to appropriate functional groups and management.
  • Provide quality customer service through coordination of return samples for investigation and follow-up activities such as replacement of product, complaint categorization, and CAPA.
Requirements

The successful candidate will have a Bachelor's Degree required or 1-3 years of relevant work experience. Preferred degree in technology or scientific background (MLT, LPN, RN). Additionally, 0-2 years' work experience in a cGMP related industry or in a clinical setting is preferred.



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