Abbott QA Complaints Coordinator in Altavista, Virginia

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

The function of the Site QA Complaints Coordinator for Altavista 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 manages:

• Site “Plant Investigation Process” Standard Operating Procedure

Effective communication with Corporate, Division, and Operations/QA Management

• Good working relationship with site QA Staff and Quality Engineers

• Reports (generates)

• Complaint information provided by the Abbott Nutrition Complaint Handling Unit

Potential high impact complaints where a potential broader issue is identified

• Physical sample evaluation (field/reference)

• Batch Record Reviews (BRR)

• Coordination and distribution of investigations to the subject matter experts (SME)

• Timeliness by maintaining and tracking Plant Investigations via the site tracking system

Periodic examination of process and/or equipment operations

• Compiled data returned by the SME’s

• Good planning, prioritizing and organizational skills

• Good communication skills (oral and written)

• Adaptability due to urgent requests (FDA, etc.)

GQMS/ABTRAQ investigations for complaints (Initiation – Event Owner)

• Single Occurrence Significant Issue Elevation (SOSIE) (initiates when needed)

• Return of “publication ready” information to the Complaint Handling Unit database for the complaint file.

Completed Plant Investigation files/records

• CAPA related projects relevant to complaint investigations

• Special project requests from various levels throughout the organization

• Job Aid for site BRR navigation system (Microsoft Access), Division Complaint Handling Unit website and conducting a comprehensive BRR

Contract personnel with directions/instructions related to complaints

• Meetings with contract personnel and QS batch auditor to communicate any new changes, etc.

• Performance feedback for contract/manufacturing personnel

• A positive attitude during increased volume of complaints (BRR and Investigations)

Aid in metric evaluation and maintenance for monthly metric meetings not limited to complaints.

• Additional work hours, if necessary

• Additional responsibilities as deemed necessary

Complaint files are handled in accordance with FDA regulations and Corporate and Division Quality Assurance policies and procedures.

Major Responsibilities:

Responsible for implementing and maintaining effectiveness of the Quality System:

  1. Coordinates the complaint investigation process for the Altavista 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 on any of the 7 filling lines at the Altavista site.

  5. Assure results of the BRR and investigation information is entered accurately into the Complaint Handling Unit database within the prescribed timeframes.

Education:

Indicate the minimum education and why it is 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

• LACF (Low Acid Canned Foods) Certified

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.

Background:

• Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.

• Ability to think independently to solve problems and trouble shoot problems expeditiously.

• Knowledge of FDA regulations including the IFA (Infant Formula Act), LACF (Low Acid Canned Foods) and cGMP (Current Good Manufacturing Practices).

• Knowledge of corporate and division policies and procedures for complaint handling as well as other pertinent procedures.

• Ability to give effective oral presentations to various plant and divisional groups.

• Ability to handle large volumes of work to juggle multiple tasks simultaneously.

• Knowledge and understanding of various computer programs including Excel, Lotus Notes, Access, GQMS (Global Quality Management System), QDMS (Quality Document Management System), Zarpac, Plant TV, QualTrend and specifically, the Abbott Nutrition Complaint Handling database

• The ability to create, manipulate and manage databases.

• Knowledge of the batch record, Division Complaint Handling Unit applications and processes involved.

• Knowledge of all products manufactured by the Altavista site

• Knowledge of stock codes, defect codes and batch codes

Accountability / Scope/Budget:

Describe the primary accountability’s of the position and the impact of actions.

• 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 Altavista 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.

The job description is illustrative of the types of duties typically performed by this job. It is not intended to be an exhaustive

listing of each and every essential function of the job. Because job content may change from time to time, the Company

Reserves the right to modify this job description at any time.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com