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Posted: Monday, January 8, 2018 7:02 AM

Job Summary

The Complaint Specialist primary responsibilities include working with various departments to investigate and respond to 3rd party and GNC complaints and ensure timely closure by meeting quality metrics set forth. This position will be responsible for writing technical responses to customers and assessing product impact of various complaints. This position will also lead and manage activities for complaint related CAPAs, and will develop trend reports to report to upper management. This position may also be involved in onsite customer visits and audits and will be responsible for responding to applicable customer inquiries.

Essential Duties and Responsibilities


* Draft technical responses to complaints prior to due date set forth in complaint procedures or specific customer quality agreement; Ensure response metric requirements are achieved

* Create and issue periodic trend reports and report on trends to management

* System administrator for the section of the electronic database (Master Control) that manages complaints

* Provide complaint data to QSC Manger on the management of complaint investigations and their status


* Responsible for receiving, reviewing processing, and analyzing all product inquiries and product complaints for manufactured and distributed products as required by applicable regulations, standards, and company policy

* Provides customer support and serves as a liaison between manufacturing facilities, distribution centers, customer/technical service and customers/patients regarding product complaints

* Partners with resources and staff on any possible adverse event or reportable complaints on product investigations and trends

* Responds to questions and liaises with fellow department staff members regarding complaint data entry and processing

* Actively participate in department process improvement efforts; Development of any required Corrective Action Plans

* Coordinate the activities related to complaint investigations involving other departments as necessary

* Request and review batch records and retains as necessary to complete complaint investigations; Request QC analysis as applicable to complete investigations

Interfaces with Customer Service and customers/patients to gather additional information required for complaint investigations, including the retrieval of product samples

* Recommend / follow up on associated corrective and preventive actions

* Provide complaint data to support customer Product Quality Reviews (PQRs) / Annual Product Reviews (APRs)

* Various duties as necessary to support the QSC department

Job Specifications

* Proficient in software programs applicable to trend analysis (Excel, Word, statistical programs a plus)

* Knowledge of electronic database (Master Control) that manages complaints

* Knowledgeable of cGMP / FDA regulatory requirements

* Strong understanding of root cause analysis and processes

* Exposure to regulatory audits

* Highly organized with strong written and verbal communication skills

* Demonstrated professional communication abilities

* Strong root cause analysis and troubleshooting skills

* Ability to interact with various departments and skill levels in a professional and consistent manner


Associated topics: accumulate, analyse, analyst, customer service, customer service analyst, data, report, statistics, support analyst


• Location: Greenville

• Post ID: 26927887 greenville is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2018