Regulatory Compliance Specialist: Audit & Substances

RXinsider LTD.; Bethlehem (Northampton County); On-site; USD 65,000 - 85,000; Full time

Job summary

RXinsider LTD. is seeking a Compliance Specialist to ensure adherence to DEA, FDA, and State Board regulations. The role may involve advisory support for processes in the DC and controlled-substance vault, reporting to the Compliance Manager.

The ideal candidate will have an Associate degree or equivalent, 1-3 years of regulatory compliance experience, and strong MS Office skills to support audits and licensure maintenance.

Qualifications

• Education: Associate degree or Equivalent level of industry knowledge
• Experience: 1-3 years of experience in Regulatory Compliance desired
• Computer Skills: Strong working knowledge of Microsoft Office Suite; Excel, Word, Outlook; experience with warehouse management and company systems

Responsibilities

• Ensure adherence to all Compliance SOPs.
• Review customer accounts for compliance with regulatory requirements for ordering controlled substances.
• Support onboarding for new and reinstated customer accounts.
• Assist in preparing and responding to customer audit requests.
• Provide support to 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 facility licensure maintenance with regulatory bodies.
• Manage access controls, records, and compliance for secure/restricted areas.
• Maintain documentation and processes for controlled substance destruction.
• Report theft, loss, or diversion to regulatory authorities as required.
• Respond to inquiries and compile information for regulatory audits and site visits.
• Perform other duties as assigned.

Skills

Regulatory Compliance

Audit Support

Documentation

Inventory Control

Access Controls

Attention to Detail

Time Management

Communication

Analytical Thinking

Accountability

Education

Associate degree or equivalent

Tools

Microsoft Office Suite

Excel

Word

Outlook

Job description

RXinsider LTD. is seeking a Compliance Specialist to ensure adherence to DEA, FDA, and State Board regulations. The role may involve advisory support for processes in the DC and controlled-substance vault, reporting to the Compliance Manager.

The ideal candidate will have an Associate degree or equivalent, 1-3 years of regulatory compliance experience, and strong MS Office skills to support audits and licensure maintenance.