IT Quality Document Specialist – Pharma / Biotech (100% Remote Based) – Home Based

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We are expanding our Quality Documentation team in the US with a Quality Document Specialist that would be office based our the Princeton Area offices or 100% remote or homebased supporting one of our pharmaceutical industry clients.

About NNIT:

NNIT is a leading global consultancy specializing in IT development, implementation, and operations for the life sciences industries. Having started life as the IT department of Novo Nordisk- Denmark’s largest pharmaceutical firm- we have pharmaceuticals and devices in our DNA. Independent for over a decade, today, NNIT has more than 2,800 employees – around 1,200 employees work outside the borders of Denmark – in China, the Czech Republic, the Philippines, Switzerland and in the US.

The QA Document Specialist supports IT Document Control Services, by performing the following duties

  • Document Numbering: On request, issue document numbers to Client employees using the Client document management system
  • Document Formatting: On request, format draft electronic documentation per Client requirements
  • Document Review & Approval: On request, facilitate the creation, revision, review, approval, pre-release and effectiveness of electronic documentation and records in the Client document management system by Client employees
  • Document Periodic Review: Facilitate the periodic review of effective electronic documentation and records in the Client document management system by Client employees
  • Document Retirement: On request, facilitate retirement of effective electronic documentation and records in the Client document management system
  • Electronic True Copy Creation: On request, create electronic copies of paper records and certify those as true copies in the Client document management system
  • Paper Records Archival: Store paper records in onsite or offsite physical archives and maintain an electronic inventory of those paper records. Facilitate recall from storage, and facilitate the modification or destruction of archived paper records.
  • Document Metadata and Classification: Review and take action to ensure appropriate classification of documents and use of metadata in the Client document management system
  • Process Metrics: Produce document control process metrics for management review and action. Process Metrics

Requirements

Candidates should have 3-5+ years working in a QA department within pharmaceutical and / or biotech with formatting and reviewing documents and be familiar with Good Documentation Practices. The positions can be based 100% remotely.

Job Types: Full-time, Contract

Experience:

  • IT Quality Document within pharma or biotech industry: 3 years (Preferred)

Apply here!

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