Quality Assurance Documentation Coordinator

About this opportunity :

As a Documentation Coordinator you will maintain quality records and operate the document control systems for the site to ensure compliance with Current Good Manufacturing Practices (cGMP) and regulatory compliance according to Title 21 CFR Part 210, 211 and ICH Q7.

Key Responsibilities: 

• Manages the electronic document control system to become the site subject matter expert with regard to operation and functionality of the electronic document control system.
• Manages document control systems and processes to ensure their integrity and compliance with cGMP regulations.
• Maintains master indices and tracking of all documents in the EDCS.
• Coordinates activities to ensure procedures are written, edited, reviewed, and approved in a timely manner to meet established deadlines.
• Assist in the development, approval, and issuance of quality system documents.
• Responsible for updating procedures specific to the Documentation Department.
• Gathering and submitting applicable quality metric reports to management.
• Work closely with other departments to support the documentation activities.
• Assist in continuous improvement activities with regard to document control.
   

Job Knowledge Required:

• A minimum of a high school diploma and 3-5 years of experience in documentation systems in a cGMP environment.
• Strong organization skills and the ability to communicate to a wide variety of audiences, potentially interacting with clients.
• Proficiency in Microsoft Office, particularly Microsoft Word, and Adobe Acrobat.