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Site Quality Complaints Coordinator

3 months ago

Tipp City, United States Abbott Full time

The Opportunity

This position works out of our Tipp City, OH location in the Abbott Nutrition division. 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, and Glucerna – to help them get the nutrients they need to live their healthiest lives.

Tipp City, Ohio, is one of Abbott’s newest nutritionmanufacturingfacilities with technology that enhances production efficiency and product quality. Join us and you’ll be part of a family that’s dedicated to innovation and excellence and dedicated to nourishing millions of families around the world.

What You'll Work On

As the Site Quality Complaints Coordinator, you’ll have the chance to work autonomously to evaluate complaint documentation and investigation information to determine what level of further investigation, if any, is required to determine a possible failure of a device/product, labeling, or packaging to meet any of its specifications. You will conduct final closure review of complaint case information and review complaint case information for correct application of procedures, codes and documentation where returned product investigation is not required in a uniform and timely manner. 

The position works under the direction of the Quality Systems Supervisor or Manager. Customer complaints 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. This position requires meticulous attention to detail of the information to be reviewed in the complaint handling process to minimize risk for error.

Complete all tasks associated with the complaint process by target dates Enter Complaint investigation information in the Trackwise Complaint database, assuring that the information is in an audit-ready state Effectively communicate with Corporate, Division and Operations/QA Management Partner with site Quality Systems, Compliance Manager, Sanitation Manager, Quality Engineers and CAPA Coordinator Develop complaints data for site Quality Management Reviews/MBR Maintain files per Abbott Record Retention policies Complete batch record reviews Coordinate cross-functional team investigations with Subject Matter Experts (SMEs) Ensure evaluation and closure of complaints are performed in a timely manner Complete ABTRAQ investigations and CAPA-related projects relevant to complaints Complete special projects requested from various levels throughout the organization Follow all Abbott Nutrition and Tipp City policies and procedures Support other Quality Systems tasks as needed

You’ll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.

Required Qualifications

Associates degree in Business, Science Technical Field or an equivalent combination of education and work experience Strong prioritization and organizational skills Adaptability due to urgent requests (FDA, etc.) The incumbent must have good written and verbal communication skills and they must possess strengths in the Abbott core competencies Ability to multi-task, drive for results and make sound business decisions independently Technical knowledge of manufacturing processes associated with processing/filling/packaging a batch  Highly proficient skills in various computer systems (i.e. Microsoft Office, etc.)

Preferred Qualifications

2 years of QA related experience (ex. Lab Analyst, Batch Log Auditor, or related position) preferred. Knowledge of the ABTRAQ CAPA system is desired. Familiarity with general medical terminology preferred.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.Pre-Employment Inquiries and Citizenship | U.S. Equal Employment Opportunity Commission (eeoc.gov)

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