Document Control Coordinator

Job Description

Duties and Responsibilities:

• Implement changes based on red-lines and format engineering documents per documentation standards.
• Ensure guidelines and definitions are consistently applied across templates and documents.
• Review all documentation for accuracy, completeness and consistency in content, format, files and authorizations.
• Filing, scanning, copying and electronic notification and distribution of released documentation.
• Store and control archived documentation.

Education and Experience:

• 2-3 years of relevant experience.
• Graduate from a recognized program in QA preferred.
• Previous QA and QMS experience.
• Previous experience working within a GMP manufacturing environment would be an asset.
• Experience working with Electronic Document Management System.
• Experience with design document engineering change orders.
• Prior experience with documentation of Life Science or Medical Device products.

Knowledge, Skills and Abilities:

• Knowledge of ISO 9001 standard required; knowledge of ISO 13485 is an advantage.
• Strong word processing skills using Microsoft Office products including application and editing of Word multilevel lists, pagination, headers/footers, tables and track changes.
• Strong communication skills, both written and verbal.
• Knowledge of document control procedures including database storage, maintenance, and revision control.

Must Haves:

• Meticulous attention to detail and strong organizational skills.
• Skilled at prioritizing in a demanding and fast paced environment while producing error free work and meeting required deadlines.
• Adept at multitasking and troubleshooting while appropriately addressing issues as they arise.
• Ability to work independently.
• Well versed in good documentation practices.
• Team Player – Thrives in a team environment to achieve a shared goal or outcome