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controlled substance specialist

4 months ago

Pleasant Prairie, Wisconsin, United States Fresenius Kabi USA, LLC Full time
Job Summary
The Controlled Substance Specialist is responsible for providing independent oversight and guidance for Distribution Center processes to ensure compliance to DEA and FDA regulatory requirements for the handling, processing, and reconciliation of controlled substance and List 1 chemical products. Provides direct non-narcotic support to area manager when not involved in monitoring the processing of controlled substances. Ensures a constant state of site readiness for all regulatory inspections and audits.
Responsibilities
  • Prepares and submits all DEA regulated documentation, including but not limited to DEA 106/107 forms, ARCOS Reporting, and perform investigations to reconcile controlled substance inventory discrepancies and perform investigations regarding the controlled substance area.
  • Responsible for the processing and storage of all DEA form 222's
  • Maintains records for controlled substances. Ensures that all inventories are performed properly, documented and reported accurately.
  • Assures compliance with all applicable state and federal laws as regulated by the State Board of Pharmacy, Drug Enforcement Agency and the Food and Drug Administration
  • Works with management and security to provide oversight for the security of controlled substance materials.
  • Serves as a subject matter expert in the interpretation of 21 CFR Part 1300.
  • Reviews controlled substance shipping and receiving documents for accuracy and compliance.
  • Reviews departmental SOPs regarding controlled substances for the Distribution Network.
  • Assists in investigations of controlled substance accountability / reconciliation issues.
  • Reviews, inspects processes and documentation to verify accuracy and compliance at critical process points.
  • Prepares DEA correspondence and informational packages as needed
  • Provides support during DEA or other regulatory or internal audits/inspections
  • Performs critical calculations as they relate to controlled substance accountability.
  • Maintains Receiving, shipping, and inventory records for controlled substances
  • Coordinates controlled substance inventory according to internal SOPs and CFR requirements
  • Supports registration activities to ensure renewals are received and processed
  • Ensures surveillance activities for controlled substances during receipt, inventory, destruction and outbound loading.
  • Represents department at meetings related to all controlled substance activities
  • Provides backup support to Controlled Substance Coordinator to complete daily tasks as required
  • Performs other related assignments and duties as required and assigned

Requirements:

  • Bachelor's Degree preferred; or a combination of 3-5 years' experience in a related field with cGMP/DEA experience in controlled substance environment.
  • Excellent verbal and written communication skills are essential. Strong attention to detail, people skills and ability to multi-task are essential for success.
  • Demonstrated knowledge as a subject matter expert and resource
  • Demonstrated understanding of 21 CFR Part 1300
  • Demonstrates the ability to independently prioritize workloads
  • Must be team oriented and able to work well with-in a cross-functional team atmosphere
  • SAP knowledge is desired
  • Knowledge of Microsoft Office products
  • Demonstrated use of sound judgement, excellent organizational skills, and detail oriented
Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.