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Fagron Sterile Services Controlled Substance Compliance Associate in Wichita, Kansas

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13503756

The Controlled Substance Compliance Associate will support the DEA compliance profile by acting as the primary entity responsible for all the logistics associated with the daily activities for all Controlled Materials at Fagron Sterile Services.

This is a dedicated position that executes the logistics associated with raw material and finished product movements and required documentation, coordinates sample inspection and transfer, VI and labeling, inventory reconciliation and correct disposal.

Additionally, the Controlled Substance Compliance Associate will ensure that all CS-related activities occur in a consistent manner, and serve as liaison to other functional area within FSS in support of an overall culture of awareness and DEA compliance.

Schedule: Friday-Sunday 6:00am-6:00pm

Key Responsibilities

  • Correct and consistent execution and documentation of all CS material transactions: Vault check-in/out, inventory reconciliation, sampling and disposal, finished product sales record. Some example include: Perpetual Inventory Records, Reverse Distributor Manifest Forms (DEA Form 222 as applicable), Transfer Forms, Yearly Reconciliation Summary Forms.
  • Support Aseptic Compounding and Filling teams throughout manufacturing process: API check-out and transfer (electronic inventory) to PROD IN, return check-in of API and finished product, recording of consumption, finished product unit and reject count verification, line flush disposal, etc.
  • Track and communicate batch release status (delays due to deviations/unplanned events), raw material availability and inventory levels.
  • Communicate with operations, post production, and FSS Labs as needed to request support as needed: VI and labeling, testing and method validations, etc.
  • Execute all inventory reconciliation and expire inventory disposal activities.
  • Maintain current electronic inventory in alignment with official paper record.
  • Continuous monitoring of material accountability records for errors, completions of review and verification signatures.
  • Assist CS Compliance Management in preparing and submitting monthly/quarterly reports (i.e. ARCOS).
  • Support operations by acting as SME in ensuring DEA and site procedure compliance for all daily activities.
  • Assist with development and growth of a Security culture among all colleagues and contractors to help ensure CS compliance.
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