Compliance Specialist - PA

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

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.

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 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:

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.

& Licenses:

None

Other Requirements:

None