Document Control Coordinator

Job Description

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