Exton, PA (Corporate)
- 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
- 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.