Compliance Specialist - TN

Posted 2 Days Ago
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Bartlett, TN, USA
In-Office
Junior
Logistics • Pharmaceutical • Manufacturing
The Role
Ensures compliance with DEA, FDA, state pharmacy, and health regulations for controlled-substance distribution. Reviews customer accounts, supports onboarding and audits, maintains controlled-substance inventory and destruction records, manages secure-area access, supports facility licensure, and reports theft, loss, or diversion to regulators. Compiles information for regulatory audits and assists compliance leadership with special projects.
Summary Generated by Built In

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. Hours Monday thru Friday (12:00 pm - 8:30 pm) Rotating Saturdays - short afternoon shift.

 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.

Essential Functions Statements

· 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 products 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.

Requirements

POSITION QUALIFICATIONS: 

Competency Statement(s)

· 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

Skills Required

  • Associate degree or equivalent level of industry knowledge
  • 1 to 3 years of regulatory compliance experience
  • Strong working knowledge of Microsoft Office Suite, including Excel, Word, and Outlook
  • Ability to work with warehouse management software and company operating systems
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The Company
125 Employees
Year Founded: 1987

What We Do

TopRx is a nationally recognized, VAWD-accredited distributor of generic pharmaceuticals, top brands, OTC products, vitamins, and pharmacy supplies. For over 37 years, the company has served as a leading distribution partner to independent pharmacies and other healthcare facilities, specializing in generic drugs to provide comprehensive product and knowledge support to its customers.

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