Quality System Specialist, III – Documentation

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

This position provides assurance of adherence to AbbVie documentation standards and principles. The role is primarily responsible for managing the creation and revision of Quality System and processes documents including assessment of proposed changes taking all controlled documentation and processes into account.  Furthermore, acts as Subject Matter Expert for Quality documentation administration (Change Control) and is the interface between Operations Documentation Management group and supports Operations PDS&T functions.  

Responsibilities:

• Ensures all administrative documentation requirements are met for supported Quality Documentation inclusive of document processing and records management.
• Facilitates the creation/revision, administration, review, and approval (as applicable) of new and revised Quality Documentation within the Document Management System (DMS)
• Maintains notifications, relations, and other property information within the Document Management System (DMS).
• Participates in supporting Operations PDS&T projects, initiatives and continuous improvement projects related to documentation management as applicable.
• Supports and coordinates document translation process as applicable.
• Provides input into overall team strategy and framework development for new and emerging initiatives (incl. mid- and long-term team goals).
• Represents Operations PDS&T on the Documentation Center of Excellence (COE)
• Administers and supports SharePoint
• Act as a records coordinator for PDS&T
• Acts as a validation coordinator for PDS&T
• Responsible for cataloging and arranging for off-site st