What are the responsibilities and job description for the Quality Systems Complaints Coordinator- Dayshift- Columbus, OH position at Abbott?
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Abbott Quality Systems Compliant Coordinator
Nourish the world and your career as part of the Nutrition team at Abbott.
Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac,
PediaSure, Pedialyte, Ensure, Glucerna and ZonePerfect – to help get the nutrients they need to live their healthiest life.
Our plant location in Columbus, OH currently has an opportunity for a Quality Compliant Coordinator. This site is Abbott’s oldest nutrition manufacturing plant in the world. Working here, you’ll feel part of a family – a family of 400 that works together to help nourish the world.
The function of the Site QA Complaints Coordinator for Columbus Plant 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.
What you'll do as a Quality Complaint Coordinator :
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.
- Manages Site “Plant Investigation Process” Standard Operating Procedure
- Good working relationship with site QA Project Leader and Quality Engineers
- Reports (generates)
- Physical sample evaluation (field / reference)
- Timeliness by maintaining and tracking Plant Investigations via the site tracking system
- Track and trend complaint related information, to meet compliance requirements.
- Periodic examination of process and / or equipment operations
- Good planning, prioritizing and organizational skills
- Good communication skills (oral and written)
- Adaptability due to urgent requests and elevations (FDA, etc.)
- Return completed information to the Complaint Handling Unit database for the complaint file
- Completed Plant Investigation files / records
- Special project requests from various levels throughout the organization
- Generate exception / CAPA documentation such as nonconformance and potential nonconformance reports and investigation reports required at the site for routine and non-routine manufacturing issues.
- Investigate aspects of the exception event and determine the root cause, product impact, risk impact, corrections, and corrective / preventive actions.
- Coordinate / facilitate meetings and / or communicate cross-functionally to develop solid solutions to CAPA activities.
- Concurrently manage multiple CAPA projects and tasks, ensuring timely completion.
- Additional work hours, if necessary Complaint files are handled in accordance with FDA regulations and Corporate and Division Quality Assurance policies and procedures.
- Reviews batch records, complaint investigations, physical samples, and trend evaluation for inclusion of appropriate documentation in the investigation of the complaint.
- Issues weekly status reports to appropriate plant management to assure efficient turn around of investigations.
- Assure results of the BRR and investigation information is entered accurately into the Complaint Handling Unit database within the prescribed timeframes.
- Ensure that all CAPA documents are written in compliance to Division policy and site procedures.
- Support site Food Safety Management with Pest Control program.
Education and Experience You'll Bring :
Required
Preferred :
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer :
