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QA Specialist III

Rosemont, IL 60018

Posted: 09/21/2022 Employment Type: Contract Job Category: Quality and Compliance Job Number: 515824 Country: United States Is job remote?: No

Job Description

Job Description Complaints QA Specialist

This Quality Assurance Specialist position will be responsible for Complaint Handling functions within the  Molecular Field and Product Quality team.

As a quality approver ensure complaint investigations are compliant with complaint handling procedures, thorough and well documented. Strong technical writing skills are required to ensure clear concise documentation that is originated or approved by QA.  Must have strong interpersonal skills to work effectively with service, technical and quality organizations. Attention to detail is a must. An ideal candidate exhibits excellent organizational skills and self-motivation. We are looking for a team player to join our team that will help deliver on team and divisional goals. Complaint handling experience required.

Daily responsibilities include:
  • Review and approve complaint investigation reports documenting determination
  • Review of new tickets assessing for accuracy of categorization (inquiry, complaint, potential reportable event)
  • Develop customer reply to convey outcome of investigations
  • Follow up on ticket status and drive to closure
  • Customer letter data gathering, drafting and routing for approval
  • Support audits by preparing requested documents

Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).

BS degree and/or 5+ years equivalent experience
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