Quality Systems Specialist III

Job Description
The Quality Systems Specialist III - Documentation, 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 RDQA QS Documentation Management group and supported R&D functions.
 
Responsibilities:
• Provides client with understanding of the AbbVie Quality System and its practical application.
• Participates in global compliance and continuous improvement projects related to Quality
System documentation.
• Ensures compliance during QS documentation creation and revision and is accountable for content design and logistics of multi- and cross-functional documentation review and approval.
• Supports development of strategy for creation of complex QS procedural documents involving cross-functional teams.
• 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 (DM)
• Maintains notifications, relations, and other property information within the Document
Management System (DMS).
• Participates in supporting R&D project and initiatives and continuous improvement projects related to documentation management as applicable.
• Supports and coordinates of document translation process (incl. Translation checking (LU only) as applicable.
• Collects and reports documentation-related key performance indicator metrics.
• Provide input into overall team strategy and framework development for new and emerging
initiatives (incl. mid- and long-term team goals).