Archivist

Archivist

Exton, PA (Corporate)

Archivist

  • Follows 21 CFR part 58.190 and any applicable guidelines and SOPs
  • Controls secure access to Frontage archives
  • Ensures appropriate archive environment
  • Controls document intake
  • Logs temporary release of documents as required by appropriate staff and timely recovery of same
  • Maintains any documentation relating to laboratory work at the Malvern site including but not limited to, logs, notebooks, training records, SOPs, protocols, raw data, reports, licenses, memoranda and any CD-ROM records included with these.  Server back-up and tape-based computer records are maintained by the IT group.
  • Controls transfer and retrieval of documents to / from external contract archive (Iron Mountain)
  • Assists the QA Director with document retrieval for audits / inspections

Document Coordinator

  • Assigns control numbers for documents, variances, deviations, change control, etc.
  • Stamps original documents and official copies / watermarks official pdfs.  Scans and assigns security to scanned documents for server storage and access
  • Maintains electronic documents on servers and issues hardcopies, as required
  • Maintains historic and current SOPs including index and hard and electronic copies.  Tracks SOP review schedules.

 

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