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Documentation Specialist (Pharmaceutical)
Ref No.: 20-00194
Location: BRANCHBURG, New Jersey
Sunrise System Inc. is currently looking for Documentation Specialist (Pharmaceutical) in Branchburg, NJ with one of our top client.
Job Title: Documentation Specialist - Pharmaceutical
Job Id: 20-00194
Location: Branchburg, NJ
Duration: 6 months +
Position Type: Hourly contract Position (W2 only)
 
Description:
Summary:
This position is responsible for processing all Client’s Branchburg (Legacy LifeCell) documentation housed in the electronic document management system (EDMS) and distributed copies used throughout Client Branchburg. This responsibility includes the Change Control Process and the distribution and archiving of all controlled paper and electronic documentation. This individual is also responsible for updating metrics and processing change controls, as required.
 
Key Duties and Responsibilities:
  • Management and processing of documents in EDMS. 40%
  • Tracking metrics for Change Control and supporting audit requests. 20%
  • Processing Change Controls, document revisions, documentation updates and reviews. 20%
  • Other duties as assigned. 20%
 
Job Qualification (Minimum Requirements):
Education and Experience:
  • BA or BS Degree, or equivalent experience - Required
  • Minimum 3 - 4 years of experience within a Documentation Services Group in Medical Device, Pharmaceutical, Human Tissue, or Biotech Industry.
  • 3 - 4 years of experience working with electronic document management systems (preferably Veeva Vault Quality Docs, TrackWise, QUMAS, etc.), as well as Change Control or Change Management systems/workflows.
  • 3 - 5 years of experience with Microsoft Office Applications including Word, Excel, PowerPoint, and Outlook; knowledge of SharePoint is a plus.
 
Essential Skills, Experience and Competencies: (includes Licenses, Credentials)
  • Experience assessing Change Control records and documentation.
  • Thorough experience reviewing, routing, and processing documents through electronic workflows in an electronic document management system.
  • In-depth knowledge and understanding of regulatory requirements pertaining to documentation management systems and change controls.
  • Demonstrated knowledge of document handling, formatting, and editing.
  • Timely reporting and ability to extract data from multiple sources for reporting and metrics purposes.
  • Able to think creatively, work quickly, and have strong attention to detail.
  • Excellent oral and technical writing skills, with the ability to interface effectively and professionally
  • Demonstrated ability to multi-task and work independently.
  • Experience with GMP and ISO 9001 Document and Data Control requirements.
  • Experience with manual records and conversion to automated systems.
 
Contact
Monik. M
Direct: (732) 272 0288 | Email: monik.m@sunrisesys.com
Or
Michael Peng
Direct: (732) 272 0265 | Michael@sunrisesys.com