Compliance Specialist - PA

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

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.

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.

Requirements

ESSENTIAL FUNCTIONS:

Reasonable Accommodations

Statement To accomplish this job successfully, an individual must be able to perform each essential function satisfactorily, with or without reasonable accommodation. Any reasonable accommodation may be provided to help enable qualified individuals with disabilities to perform the 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

• Accountability - Ability to accept responsibility and account for his/her actions.
• Analytical Skills - Ability to use thinking and reasoning to solve a problem.
• Assertiveness - Ability to act in a self-confident manner to facilitate completion of a work assignment or to defend a position or idea.
• Communication, Oral - Ability to communicate effectively with others using the spoken word.
• Decision Making - Ability to make critical decisions while following company procedures.
• Tactful - Ability to show consideration for and maintain good relations with others.Accuracy - Ability to perform work accurately and thoroughly.Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.Time Management Skills - Ability to organize and direct oneself in a fast paced, time sensitive environment.Honesty / Integrity - Ability to be truthful and be seen as credible in the workplace.Detail Oriented - Ability to pay attention to the minute details of a project or task.
• Organized - Possessing the trait of being organized or following a systematic method of performing a task.

Skills & Abilities

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