Quality Complaints Coordinator

Company: Alora Pharmaceuticals, LLC
Location: Alpharetta
Posted on: July 31, 2022

Job Description:

Complaint CoordinatorJob Description The Complaint Coordinator will be responsible for the management of complaints from initiation to closure 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 an electronic quality document management system.
• Evaluate the complaint information and determine the depth of the required investigations.
• Initiate investigation requests with both internal teams and external suppliers.
• Notify Senior Management of complaints with significant quality or compliance issues that might require a Field Alert/Recall.
• Conduct complaint investigations and write investigation reports.
• Review complaint investigations conducted by internal teams and external suppliers.
• Track closure of complaint investigations and associated CAPAs that may be generated as a result of the complaint.
• Ensure assigned complaints are closed within the procedurally defined timelines.
• 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.
• Assist Medical Affairs and contracted pharmacovigilance vendors as needed by providing information necessary for pharmacovigilance assessments.
• Assist with the generation of complaint system metrics and trending reports.
• Perform complaint risk assessments.
• Ensure the proper storage of complaint samples.
• Perform additional duties and responsibilities as assigned by Quality Management. Basic Qualifications
  • A Bachelors degree preferred and/or 4 years of related work experience. 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 when guided by documented procedures.
      • 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.
      • Strong oral and written communication skills.
      • Proficient with Microsoft office applications.

Keywords: Alora Pharmaceuticals, LLC, Alpharetta , Quality Complaints Coordinator, Other , Alpharetta, Georgia