Quality Assurance Coordinator - Controlled Substances

Über die Tätigkeit

We are seeking a Controlled Substances Coordinator to join our Quality Assurance team in St. Paul, MN. This role 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 Inc.  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, inventory reconciliation and correct disposal.  Additionally, the QA Controlled Substances Coordinator will ensure that all CS-related activities occur in a consistent manner, and serve as liaison to other functional areas within Fagron Inc., in support of an overall culture of awareness and DEA compliance.

Key Responsibilities

  • Accurate and consistent documentation and execution of all CS transactions including: Cage check-in/out, inventory reconciliation, sampling and disposal, raw material availability and inventory levels, bulk to finished product batch releases and record keeping.
  • Maintain current electronic inventory in alignment with official paper record.
  • Perform due diligence checks on CII customer orders including the Letters of Intent, DEA Registration Validation, and the DEA Form 222.
  • Complete DEA Form 222 & Procurement Quota letters for all CII purchases.
  • CIII-CIV Imports and Exports: Coordinate shipments with Vendors, apply for the appropriate DEA (236, 357, or 161) Forms, and report the incoming or outgoing transactions.
  • Apply for and maintain the annual CII Quota Procurement Allotment (DEA Form 250) & Revised Quota Requests.
  • Annual DEA Registration Renewals for the Fagron Inc. Import, Export, and Manufacturer Licenses.
  • Prepare and submit monthly DEA ARCOS, DEA Form 452 (Tablet and Encapsulating Machines) reports, and required monthly/quarterly state reports.
  • Support operations by acting as the subject matter expert 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 DEA compliance.
  • Maintain and revise CS-related Master Control documents.
  • Other duties as assigned

Ihr Profil

You possess the following qualifications, background and abilities:

  • Highschool diploma or equivalent required, 2 or 4 year college degree preferred.
  • Must be able to meet all requirements for handling of controlled substances.
  • Working knowledge of GDP and GMP principles pertaining to a pharmaceutical manufacturing environment.
  • Previous work experience in a regulated manufacturing or pharmacy type setting a plus.
  • Excellent time-management skills and ability to self-direct in managing concurrent requirements.
  • Ability to communicate with others in person and on the phone, or by written communication in a clear, straight-forward, and professional manner in order to clearly convey priorities and needs.
  • Excellent attention to detail and commitment to maintaining consistency and compliance with established procedures.
  • Proactive, problem-solving mindset – ability to identify and correct errors, offer improvement recommendations, and willingness to embrace ownership of complex process.

Unser Angebot

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron US offers its associates competitive compensation and a wide range of benefits including a 401(k) plan with a generous company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

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