Clinical Affair Document Control Specialist

Role: Clinical Affair Document Control Specialist
Location: Lake Forest, Illinois - 60045
Duration: 12+ Months on W2
Shift Timings: 8:00 AM to 5:30 PM

Core Job Responsibilities
Ensure compliance with applicable Corporate and Divisional Policies and procedures.
A Clinical Affairs Document Control Specialist should demonstrate excellent quality of work in the following activities:
Manage document change requests, reports and all other regulated/controlled documentation.
Maintain and review consistency checks for document formats and contents.
Conduct Full Text Searches.
Coordinate with Learning for training material revisions.
Schedule and manage process community meetings.
Facilitate communications (e.g., announcements, reminders, consolidation of comments).
Effectively maintain document redlines using Microsoft Word.
Assist with documenting: Change/ Reasons/ Justifications.
Maintain quality system Change Request submissions and statuses.
Generate monthly metrics.
Assist with quality system gap assessments.
Maintain organized files.
Utilize multiple computer applications used to manage document assessments and CAPA investigations.
Act as preparer or verifier of documentation
Assist with CAPA-related activities and documentation.