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The function of the Site QA Complaints Coordinator for Quality Assurance is to coordinate product improvement efforts through investigation of customer complaints. The complaints recorded are for adult nutritional, pediatric nutritional and Third Party Manufactured (TPM) products and are received from the United States, Canada and International affiliates worldwide. The objective of the Site Complaints Coordinator is to collect, investigate and report complaint information so that corrective actions can be initiated and implemented to improve our products for our customers. Through this process, loss in sales and market share can be prevented. To reach this objective, the Site Complaints Coordinator performs the following:
- Comply with the site Plant Investigation Process Standard Operating Procedure
- Maintains effective communication with Corporate, Division, and Operations/QA Management
- Maintains a good working relationship with site QA Project Leader and Quality Engineers
- Generates reports from databases and other systems.
- Addresses complaint information provided by the Abbott Nutrition Complaint Handling Unit
- Addresses potential high impact complaints where a potential broader issue is identified
- Evaluates physical sample (field/reference)
- Reviews Batch Records
- Coordinates and distributes investigations to the subject matter experts (SME)
- Maintains and tracks Plant Investigations via the site tracking system in a timely manner
- Examines process and/or equipment operations periodically
- Compiles data returned by the SME's
- Use ABTRAQ for investigations for complaints (Initiation - Event Owner status)
- Participate in on market events and Division Complaint meetings
- Return publication ready information to the Complaint Handling Unit database for the complaint file.
- Complete Plant Investigation files/records
- Knowledge of stock codes, defect codes and batch codes
- Perform CAPA related projects relevant to complaint investigations
- Perform special project requests from various levels throughout the organization
- As needed Assess Pest Control Plant Information Reports by maintaining an accurate file and assuring the appropriate management review has been completed and signatures present per Standard Operating Procedures (SOP)
- As needed Assess Monthly Pest Control Trend Reports by maintaining an accurate file and assuring the appropriate signatures are present per SOP
- Retain Pest Control/Fumigation Records (QSRC05)
- Participate in external and internal audit activities
- Keep the Job Aid for site Batch Records navigation system, Division Complaint Handling Unit website and conducting a comprehensive BRR current
- Work with contingent personnel and provide directions/instructions related to complaints
- Ensure there is back up for one QS batch auditor (BRR back-up) with directions/instructions related to completing BRR investigations when absent complaints
- Hold meetings with contingent personnel and QS batch auditors to communicate any new changes, etc.
- Provide performance feedback for contingent personnel to site leaders
- Participate in internal and external preparations, execution and follow up.
- Work additional hours on rush complaints, if necessary
Complaint files are handled in accordance with FDA regulations and Corporate and Division Quality Assurance policies and procedures.
Responsible for implementing and maintaining effectiveness of the Quality System:
1. Coordinates the complaint investigation process for the plant in compliance with FDA Regulations and Abbott policies and procedures.
2. Reviews batch records, complaint investigations, physical samples, and trend evaluation for inclusion of appropriate documentation in the investigation of the complaint.
3. Issues weekly status reports to appropriate plant management to assure efficient turn around of investigations.
4. Notifies appropriate management (plant and division) of noted trends
5. Assure results of the batch records and investigation information is entered accurately into the Complaint Handling Unit database within the prescribed timeframes.
6. Assist with Maintains all site Pest Control documentation.
7. Participate in Internal and External audit activities
- High School Diploma/GED required
- Bachelor's Degree preferred or A combination of 2 yrs manufacturing experience with 2 yrs Quality Assurance experience or 4 yrs total Quality Assurance experience and
- HACCP, Preventative Controls, LACF (Low Acid Canned Foods) Certified Preferred
The position requires the ability to plan, understand often complex complaint issues, coordinate with other professionals and make appropriate decisions to solve problems and gather necessary information. Sound judgment is required to determine the adequacy of the complaint investigations.
- Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.
- Ability to think independently to solve problems and trouble shoot problems expeditiously.
- Preferred: Knowledge of FDA regulations including the IFA (Infant Formula Act), LACF (Low Acid Canned Foods) and cGMP (Current Good Manufacturing Practices).
- Good writing skills and Ability to give effective oral presentations to various plant and divisional groups.
- Ability to handle large volumes of work to juggle multiple tasks simultaneously.
- Ability to work with databases, computer systems, spreadsheets
- Knowledge of the batch records and complaint policies
- Preferred: Knowledge of all products manufactured by the Casa Grande site
- Ability to work with a high degree of autonomy, independent thinking and self-sufficiency required in the performance of the job.
- Ability to meet target dates and daily responsibilities that are required.
- Ability to plan and understand often complex complaint issues, coordinate with other professionals and make appropriate decisions to solve problems and gather necessary information.
- Good general planning, prioritizing and organizational skills
- Good general communication skills (oral and written)
- Adaptability due to urgent requests (FDA, etc.)
- Ability to maintain a professional positive attitude during increased volume of complaints (BRR and Investigations) and during audit
The complaint area is an area of high regulatory exposure. A properly handled complaint may restore customer loyalty while an improperly handled complaint may mean loss of business, litigation, adverse media attention or a product recall. With the numerous sources of information needed to be reviewed in the complaint handling process, and the high volume of complaints reported for the Casa Grande site there is a high risk for potential error to occur. This position requires meticulous attention to detail to minimize that risk for error. If an error isn't caught and is found by FDA, Corporate, Division or Third-Party auditors, the outcome could be observations or field actions.
- There is high degree of autonomy, independent thinking and self-sufficiency required in the performance of the job.
- The job has target dates and daily responsibilities that are required to be met for the smooth continual operation of the Quality Assurance department. It is the individual's responsibility to meet those dates.
- Supervision/Management is provided for training, direction in handling unusual events and in guidance for special projects requested by upper management.