Description
ResponsibilitiesAssess all DEA activities and advise management on implementation opportunities for process improvements
Coordinate all year end physical inventory activities for the submission of DEA Licenses including: discrepancy investigations, balancing inventories for transfers, shipments, receipts, site returns and destructions to reconcile the drug within the allowable accountability percentage
Ensure controls are in place and that substantiating documentation is approved and available for all licenses so that they pass independent and governmental audits.
Responsible for the production of monthly reports including un-blinding and reconciliation of the data by part number and 222 form for quarterly DEA ARCOS submission:
- Receiving
- Transfers
- Shipments
- Returns
- Destruction
Manage the coordination of 222 Forms for completion including:
- Purchases, Quota Request/Availability
- Transfers/Transfer Memos
- Shipments
- Destruction
- Site Returns
Attend Client meetings, as applicable, when launching a new clinical protocol; including providing expertise in mocking up 222 Forms
At the close of a study, confirm and coordinate documentation with Returns in order for FCS to receive scheduled drug returned product.
Skills:
Laws, regulations, and rules governing work requirements for FDA and DEA participants.
Must have knowledge / experience of 222 forms
Applies Good Manufacturing Practices in all areas of responsibility.
BS Degree or 3-5 years of equivalent experience.
Language - ability to read and interpret documents such as FDA and DEA guidelines and regulations.
Junior level positions / Admin level sough
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