Customer Complaint Quality Coordinator
Company: Avion Pharmaceuticals
Posted on: June 20, 2022
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
- 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
- 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
- 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
- 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,
- Basic competence with medical and therapeutic terminology.
- Basic understanding of patient safety regulatory
- Familiarity with regulatory and pharmacovigilance guidelines,
- 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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