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Customer Complaint Quality Coordinator

Company: Avion Pharmaceuticals
Location: Alpharetta
Posted on: June 20, 2022

Job Description:

Customer Complaint Quality CoordinatorJob DescriptionThe Customer Complaint Quality Coordinator will be the first point of quality contact for complaints and ensure that complaints are managed in accordance with site SOP and regulatory guidance. The position will be required to conduct and write complaint investigations independently.Key Responsibilities/Essential Functions

  • Record and monitor consumer complaints in a validated document management system (MasterControl).
  • Evaluate the complaint and determine the level and rationale for the investigation.
  • Triage and initiate investigation requests with both internal team and external suppliers.
  • Notify Senior Management of complaints with significant quality or compliance issues that might require a Field Alert/Recall according to the Management Notification SOP.
  • Conduct complaint investigations and write investigation reports.
  • Review complaints and conclusions from complaint investigations conducted by contracted facilities.
  • Track closure of complaint investigations and associated CAPA's that may be generated at the Product Owner or contract facility sites as a result of the complaint.
  • Approve extensions for complaints that go beyond the specified time periods in the Quality Agreement for completion of the investigation.
  • Provide a written response to the consumer/customer stating the outcome of the investigation.
  • Contact the complainant, as warranted, to obtain complaint samples for evaluation/testing.
  • Work with Vendors associated with the product that may have contributed to the event.
  • Assist medical advisors as needed.
  • Respond to technical queries related to the products.
  • Assist the Drug Safety management, Regulatory Affairs or delegates as required.
  • Work with pharmacovigilance service providers as required.
  • Prepare metrics and trending reports.
  • Perform complaint risk assessments.
  • Ensure the proper storage of complaint samples.
  • Assist in other functions in the department as needed.Basic Qualifications
    • A Bachelor's degree is required; a Bachelor's degree in a scientific or technical field, preferred.
    • Minimum of 2 years of quality experience in a cGMP environment; 2 years of product and service complaint handling experience, preferred.
    • Basic competence with medical and therapeutic terminology.
    • Basic understanding of patient safety regulatory obligations.
    • Familiarity with regulatory and pharmacovigilance guidelines, preferred.Other Requirements
      • Ability to work independently but guided by documented procedures, with appropriate support. Able to work effectively as part of a team.
      • Excellent attention to detail.
      • Ability to deliver within established timelines.
      • Fluency in English and excellent comprehension.Proficient with Microsoft office applications.

Keywords: Avion Pharmaceuticals, Alpharetta , Customer Complaint Quality Coordinator, Other , Alpharetta, Georgia

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