Job Purpose:

Coordinate document control activities for Document Specialists, as well as performing review and approval of documents, administering the Livelink Electronic Document Management System and training the users on Livelink.

• Coordinate document control activities for Document Specialists
• Act as On-the-Job trainer for Document Specialists
• Perform user training for Livelink Electronic Document Management System.
• Perform Document Control activities within Livelink EDMS such as verification of form completion, troubleshooting workflows and report generation
• Ensure adherence to the Standard Operating Procedures that govern the use of the Livelink Electronic Document Management System.
• Format and edit documents, including Standard Operating Procedures, Specifications, Controlled Forms, and Policies that support GMP operations and comply with cGMP and FDA guidelines, and additional quality standards addressed in Novartis’ Quality Manual.
• Provide consistent document format to achieve uniformity of all site documents.
• Generate Holly Springs document management system SOPs
• Report KPIs to management

• Must have excellent communication skills and strict attention to detail.
• Must be flexible, able to multi-task in a fast-paced environment, and operate well in a team setting.
• Must be able to proof work and identify non-standard format or wording, and errors within documents.
• Must have the ability to coordinate the work of others.
• Must have the ability to facilitate training sessions.

• Customer satisfaction.
• Timely completion of document control activities within Livelink EDMS
• Timely reporting of KPIs

• Bachelors Degree
• 5-8 years experience in QA document control function, preferred.
• Minimum 2 years coordinating the work of others.
• Minimum 2-years technical word processing experience.
• Minimum 1 year training experience.
• Must have experience working with an Electronic Document Management Experience.
• Must be highly skilled in Microsoft Word, Outlook, Excel and experienced with PC’s and databases.
• Knowledge of Good Manufacturing Practices (GMPs). Job Purpose:
  Coordinate document control activities for Document Specialists, as well as performing review and approval of documents, administering the Livelink Electronic Document Management System and training the users on Livelink.
  Major Accountabilities:
  • Coordinate document control activities for Document Specialists
  • Act as On-the-Job trainer for Document Specialists
  • Perform user training for Livelink Electronic Document Management System.
  • Perform Document Control activities within Livelink EDMS such as verification of form completion, troubleshooting workflows and report generation
  • Ensure adherence to the Standard Operating Procedures that govern the use of the Livelink Electronic Document Management System.
  • Format and edit documents, including Standard Operating Procedures, Specifications, Controlled Forms, and Policies that support GMP operations and comply with cGMP and FDA guidelines, and additional quality standards addressed in Novartis’ Quality Manual.
  • Provide consistent document format to achieve uniformity of all site documents.
  • Generate Holly Springs document management system SOPs
  • Report KPIs to management
  General:
  • Must have excellent communication skills and strict attention to detail.
  • Must be flexible, able to multi-task in a fast-paced environment, and operate well in a team setting.
  • Must be able to proof work and identify non-standard format or wording, and errors within documents.
  • Must have the ability to coordinate the work of others.
  • Must have the ability to facilitate training sessions.
  Key Performance Indicators:
  • Customer satisfaction.
  • Timely completion of document control activities within Livelink EDMS
  • Timely reporting of KPIs
  Ideal Background:
  • Bachelors Degree
  • 5-8 years experience in QA document control function, preferred.
  • Minimum 2 years coordinating the work of others.
  • Minimum 2-years technical word processing experience.
  • Minimum 1 year training experience.
  • Must have experience working with an Electronic Document Management Experience.
  • Must be highly skilled in Microsoft Word, Outlook, Excel and experienced with PC’s and databases.
  • Knowledge of Good Manufacturing Practices (GMPs).
    NOTE: Position can and may be upgraded or downgraded based upon years of experience and technical competencies.
    
    Novartis Vaccines & Diagnotics is a new division of Novartis consisting of two businesses focusing on the development of preventive treatments and tools. Novartis Vaccines is the world's fifth largest vaccines manufacturer and second-largest of flu vaccines in the United States an equal opportunity employer.