Regulatory Compliance Specialist: Audits & Controls

Top-Rx-LLC; Town of Bethlehem (NY); On-site; USD 70,000 - 90,000; Full time

Job summary

Top-Rx-LLC in Town of Bethlehem, NY, seeks a Compliance Specialist to ensure adherence to DEA, FDA, and state regulations. The role may advise on processes in the distribution center and controlled-substance areas, reporting to the Compliance Manager.

The successful candidate will review accounts for controlled substance ordering, support onboarding, and assist in audits. Strong analytical, organizational, and communication skills are essential to maintain accurate records and licensing.

Qualifications

• Bachelor? Not specified in text; Associate degree or equivalent level of industry knowledge is required.
• 1-3 years of experience in Regulatory Compliance desired.
• Must have strong working knowledge of Microsoft Office Suite and able to work with warehouse management software and company operating systems.

Responsibilities

• Ensure adherence to all Compliance 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.
• 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.

Skills

Analytical skills

Time management

Detail oriented

Communication

Problem solving

Accountability

Education

Associate degree

Tools

Microsoft Excel

Microsoft Word

Microsoft Outlook

Warehouse management software

Job description

Top-Rx-LLC in Town of Bethlehem, NY, seeks a Compliance Specialist to ensure adherence to DEA, FDA, and state regulations. The role may advise on processes in the distribution center and controlled-substance areas, reporting to the Compliance Manager.

The successful candidate will review accounts for controlled substance ordering, support onboarding, and assist in audits. Strong analytical, organizational, and communication skills are essential to maintain accurate records and licensing.