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Compliance Support Administrator - PA

TopRx

Bethlehem, PAOnsitePosted 23 days ago$21.00/hour
Full TimeEntry LevelRegulatory Affairs
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Summary

This position is responsible for ensuring compliance with all applicable state and federal regulations, including those of the Drug Enforcement Administration, the FDA, and the State Board of Pharmacy or Department of Health. This position may also serve in a staff (advisory) capacity for processes related to compliance within the Distribution Center and the controlled-substance cage and vault. This position reports directly to the Compliance Manager.

Job description

Position Summary

This position is responsible for ensuring compliance with all applicable state and federal regulations, including those of the Drug Enforcement Administration, the FDA, and the State Board of Pharmacy or Department of Health. This position may also serve in a staff (advisory) capacity for processes related to compliance within the Distribution Center and the controlled-substance cage and vault. This position reports directly to the Compliance Manager.

Essential Functions

  • Ensure adherence to all Compliance Standard Operating Procedures (SOPs).
  • Review customer accounts that request the ability to order controlled substances for compliance with regulatory requirements.
  • Support onboarding for new and reinstated customer accounts.
  • Assist in preparing and responding to customer audit requests.
  • Provide support to other Compliance Specialists, the Compliance Manager, and the Director of Compliance as needed.
  • Contribute to special projects as assigned.
  • Maintain accurate inventory accountability records for all controlled substances.
  • Support the maintenance of facility licensure with all applicable governing bodies.
  • Manage access controls, records, and compliance for secure/restricted areas.
  • Maintain documentation and processes for controlled substance destruction.
  • Report theft, loss, or diversion of product to regulatory authorities in accordance with applicable regulations.
  • Respond to inquiries and compile information for regulatory audits and site visits.
  • Perform other duties as assigned.

Position Qualifications

Education: Associate degree or Equivalent level of industry knowledge

Experience: 1 -3 years of experience in Regulatory Compliance desired

Computer Skills: Must have a strong working knowledge of the Microsoft Office Suite of products with specific knowledge of Excel, Word, and Outlook. In addition, must be able to work fluidly with the warehouse management software and the company operating software and systems to function effectively in this position.

Certifications & Licenses: None

Other Requirements: None

Requirements

  • Associate degree or equivalent industry knowledge
  • 1-3 years of experience in Regulatory Compliance desired
  • Strong working knowledge of Microsoft Office Suite (Excel, Word, Outlook)
  • Ability to work with warehouse management software and company operating systems
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