Job Purpose:

Responsible for site GMP records and archives. Catalogue, archive, and issue con-trolled documents and records, including Batch Production Records, Standard Operating Procedures, Validation Protocols, Project Documents, and other controlled forms that support cGMP operations.

• Catalogue and archive GMP documents in a secure location.
• Assist in searching, locating, obtaining and distributing documents and records.
• Coordinate document control activities for Records Specialists
• Act as On-the-Job trainer for Records Specialists
• Input, compute and track all archival information and project related information.
• Generate and maintain records management SOPs
• Act as the system administrator for the records management system
• 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 records function preferred
• 2 years coordinating the work of others preferred.
• Must be highly skilled in Microsoft Word, Outlook, Excel and experienced with PC’s and databases.
• Knowledge of Good Manufacturing Practices (GMPs).
• Very good communication skills, in both verbal and written form.
• Ability to coordinate the work of others.
• Excellent interpersonal relationship skills necessary for effective oversight.
• A self-starter with tenacity and the ability to follow up on and complete multiple projects simultaneously. Job Purpose:
  Responsible for site GMP records and archives. Catalogue, archive, and issue con-trolled documents and records, including Batch Production Records, Standard Operating Procedures, Validation Protocols, Project Documents, and other controlled forms that support cGMP operations.
  Major Accountabilities:
  • Catalogue and archive GMP documents in a secure location.
  • Assist in searching, locating, obtaining and distributing documents and records.
  • Coordinate document control activities for Records Specialists
  • Act as On-the-Job trainer for Records Specialists
  • Input, compute and track all archival information and project related information.
  • Generate and maintain records management SOPs
  • Act as the system administrator for the records management system
  • Report KPIs to management
  General: 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 records function preferred
  • 2 years coordinating the work of others preferred.
  • Must be highly skilled in Microsoft Word, Outlook, Excel and experienced with PC’s and databases.
  • Knowledge of Good Manufacturing Practices (GMPs).
  • Very good communication skills, in both verbal and written form.
  • Ability to coordinate the work of others.
  • Excellent interpersonal relationship skills necessary for effective oversight.
  • A self-starter with tenacity and the ability to follow up on and complete multiple projects simultaneously.
    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.