DEA Compliance Specialist Job at Pharmaceutics International Inc

Pharmaceutics International Inc Hunt Valley, MD 21031

Our team of 250 is poised to expand, and we're eager to welcome passionate new members. We look for candidates driven by challenge and committed to making a lasting impact on our business as well as the lives of our clients. Join us in shaping the future!

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In this role you will:*
Perform the day-to-day activities of the DEA Compliance program, as well as ensure compliance with all federal and state regulations and requirements.
Be responsible for the DEA Form 222 issuance and management for all required CDS movements. Maintain all records related to DEA FORM 222s within their perspective binders.

  • Prepare and complete all DEA ARCOS (quarterly) and YERS (year-end) reports on a timely basis.
  • Maintain daily log reports of all DEA vaults and cages.
  • Receipt, inspection, and securement of CDS shipments upon arrival at Pii loading docks and transfer to DEA cage or vault.
  • Manage procurement quotas of CDS.
  • Complete and submit applications for DEA License renewals in a timely manner.
  • Ensure transfer of requested CDS between Pii buildings following DEA stipulations.
  • Collect and submit CDS rejects and manufacture waste for destruction by utilizing DEA form# 41. Arrange for destruction with a reverse distributor.
  • Maintain security of DEA vaults and cages.
  • Manage and record all movement of CDS into and out of DEA vaults and cages.
  • Maintain & manage Pii's NDC system and logbook
  • Prepare and apply for all Impo1t & Export DEA applications for controlled substances.
  • Knowledge of and ability to apply cGMP regulations and DEA regulations pertaining to controlled substances.
  • Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring objects into sharp focus, and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
  • Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.
  • Occasionally in proximity to moving mechanical parts, laboratory equipment, and exposure to chemicals.
  • Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).

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To be successful in this role, your background and experience should include:*

  • Minimum of two years experience in the pharmaceutical industry with at least two years in DEA Compliance, or relevant experience in a related field.
  • Knowledge of cGMP regulations and DEA regulations pertaining to controlled substances.
  • Demonstrate interpersonal skills to develop and maintain strong working relationships with diverse individuals and work groups in a multi-disciplinary environment.
  • Strong oral and written communication skills, with the ability to be clear and succinct in a variety of communication settings and styles; including reports, presentations, and technical documents.
  • Advanced organizational skills to complete multiple activities and projects on time and within defined scope/requirements.
  • Demonstrate expertise in utilizing contemporary tools to meet current and advancing cGMP requirements.
  • Demonstrate effective multi-tasking

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Bachelor’s degree in Chemistry, Pharmacy, Microbiology, or related field preferred; or equivalent combination of education and pertinent, progressive experience in pharmaceutical or other highly regulated industry.*
The DEA Custodian must work on site.

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What can Pii offer you? (Besides an amazing and innovative culture?)*

  • All Inclusive - Full Benefits Package.
  • PTO Package
  • Company Social Events
  • Team Member Assistance Program
  • Professional Support & Development
  • MUCH MORE!!

If you want the reward of major professional development and growth in a smaller organization while learning valuable new skills in a cutting-edge pharmaceutical development and manufacturing organization Pii may be the place for you.

Job Type: Full-time




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