Job Details

JOB TITLE: Document Control Coordinator (Entry Level)

JOB LOCATION: Carlsbad, CA (Onsite Position)

Contract Duration: 12 months

JOB DESCRIPTION:
· 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.

Success Factors
· 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

Education and/or Work Experience Requirements:
· 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.
· Knowledge of ISO 9001 standard required; knowledge of ISO 13485 is an advantage
· Prior experience with documentation of Life Science or Medical Device products.
· 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.
· Experience with design document engineering change orders.
· Knowledge of document control procedures including database storage, maintenance, and revision control