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QA Product Support Specialist

at Abbott Laboratories in Westbrook, Maine, United States

Job Description

QA PRODUCT SUPPORT SPECIALIST: Abbott Diagnostics Scarborough, Inc. - Westbrook, ME

Manage the site Customer Complaint Investigation Program, including responsibility for deciding which complaints will be investigated and how they will be investigated. Coordinate data generating activities, evaluate data and write investigation summaries/conclusions. Comply with cGMP regulations for medical devices and/or biologics including compliance for quality record documentation requirements. Maintain effective communication with Technical Service groups (worldwide locations) regarding product complaint investigations. Perform Post Market Surveillance activities as required. Identify events that may be subject to vigilance reporting requirements and communicate to Regulatory for evaluation. Review and reconcile complaint records for accuracy and completeness. Communicate with worldwide Technical Service teams to obtain and reconcile complaint record details. Assess and determine if a complaint requires an investigation including determining and assigning appropriate investigation actions. Determine the complaint investigation priority and level of risk associated. Complete investigation actions including data generation activities to determine if any rates are out of expected trend. Escalate complaints to Quality Incident and/or Corrective and Preventive Actions (CAPA) investigations based on complaint investigation findings and participate as part of cross-functional investigation team for those Quality Investigations. Assess and determine if a complaint is a potentially Reportable Event (pRE) and communicating escalation to Regulatory Affairs. Demonstrate understanding of lab practices in regards to manufactured products within a clinical setting. Manage complex programs and database software including Excel data queries with PowerBI, Salesforce, and other document control systems such as Agile and ENSUR. Carry out duties in compliance with established business policies. Conduct other duties as assigned, which may include training/supporting new hires, providing feedback with determining new process pathways, and assisting with writing procedures and workflows as indicated.

Bachelor’s or foreign equivalent degree in Engineering, Biology, Chemistry, Life Sciences, or in a closely related scientific or engineering field of study with at least 1 year of professional experience in: (i) cGMP regulations for medical devices and/or biologics, (ii) escalating complaints to Quality Incident and/or Corrective and Preventive Actions (CAPA) investigations based on complaint investigation findings; and (iii) managing complex programs and database software  including Excel data queries with PowerBI, Salesforce, and other document control systems such as Agile and ENSUR.  

An EOE. 40 hrs/wk. Respond by mail: Abbott Laboratories, Kathleen Ellwanger, Senior Paralegal, 100 Abbott Park Road, Bldg AP6A, Dept 32RC, Abbott Park, IL 60064-3500.  Refer to ad code: ABT-00726-KE.

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Job Posting: 826421

Posted On: Sep 30, 2022

Updated On: Oct 31, 2022