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R&D Documentation Coordinator

Edison-New Brunswick Metro Area, NJ

Posted: 06/07/2019 Job Type: Scientific Job Number: JN -062019-25042
JOB SUMMARY:

The R&D Documentation/Change Control Coordinator will facilitate and coordinate all aspects of the R&D Documentation process. The position also requires the maintenance of electronic and manual archives.

Main Job Duties:
  • Maintain filing and storage area for all R&D Study Records, Lab Notebooks, Design History Files, and Histology slides
  • Assign R&D Study numbers
  • Assign memo numbers
  • Assign Lab Notebooks and perform routine Lab Notebook audits
  • Update and maintain electronic and manual archive of lot Device History Files
  • File and retrieve documents and files as needed.
  • Prepare documents and lab notebooks for Off-Site storage
  • Support the creation of new and revisions to existing documents (i.e. policies, procedures, work instructions, and forms).
  • Support of records related issues during internal and external audits

JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):
Education and Experience:
  • HS Degree
  • Essential knowledge of MS Office (Word/Excel)
  • 1-2 years experience working in a documentation control environment
  • Good communications skills and ability to multi-task and work independently
  • Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
  • Knowledge of electronic document control systems
Previous experience to include pharmaceutical/medical device regulated companies
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