Regulatory Compliance Specialist (DEA/FDA)

TopRx; Bethlehem (Northampton County); On-site; USD 65,000 - 90,000; Full time

Job summary

TopRx is seeking a Compliance Specialist to ensure adherence to federal and state regulations, including DEA, FDA, and State Boards. The role supports the Compliance Manager and may advise on processes within the Distribution Center and controlled-substance areas.

Responsibilities include onboarding, audit responses, inventory accountability for controlled substances, and licensure maintenance. The role reports to the Compliance Manager and requires 1-3 years in regulatory compliance and strong

Qualifications

• Associate degree or equivalent level of industry knowledge.
• 1-3 years of experience in Regulatory Compliance desired.
• Strong working knowledge of Microsoft Office Suite; able to work with warehouse and company operating software.

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.
• Contribute to special projects as assigned.
• Maintain accurate inventory accountability records for all controlled substances.
• Support maintenance of facility licensure with governing bodies.
• Manage access controls, records, and compliance for restricted areas.
• Maintain documentation and processes for controlled substance destruction.
• Report theft, loss, or diversion of product to regulatory authorities.
• Respond to inquiries and compile information for regulatory audits and site visits.
• Perform other duties as assigned.

Skills

Accountability

Analytical skills

Assertiveness

Communication

Decision making

Tactful

Accuracy

Problem solving

Time management

Honesty

Detail oriented

Organized

Education

Associate degree

Tools

Microsoft Office

Excel

Word

Outlook

Warehouse Management System (WMS)

Job description

TopRx is seeking a Compliance Specialist to ensure adherence to federal and state regulations, including DEA, FDA, and State Boards. The role supports the Compliance Manager and may advise on processes within the Distribution Center and controlled-substance areas.

Responsibilities include onboarding, audit responses, inventory accountability for controlled substances, and licensure maintenance. The role reports to the Compliance Manager and requires 1-3 years in regulatory compliance and strong