Compliance Specialist 503b

4 weeks ago

Houston, United States Empower Pharmacy Full time

Position Summary:
Elevate the standards of pharmaceutical compliance and ignite your career as a 503B Compliance Specialist at Empower. In this role, you will be at the forefront of overseeing and enforcing adherence to critical regulatory frameworks, including those governed by the DEA, FDA and State Boards of Pharmacy. Your meticulous attention to detail will ensure that all operations involving controlled substances, from their initial receipt to the final point of dispensation, meet the highest standards of regulatory compliance.

Under the leadership of our Compliance Manager, your role will be more than monitoring and managing; you'll be a key player in transforming industry practices. You'll spearhead initiatives that refine our processes, making them not only compliant but also more efficient and responsive to the needs of today's healthcare landscape. Your work will directly contribute to maintaining Empower’s reputation for integrity and quality, impacting the lives of countless individuals by ensuring the safe and lawful management of medications.

Are you ready to challenge yourself in a dynamic, fast-paced environment? Are you driven by a commitment to excellence and a desire to make a lasting impact? Join Empower and become a vital part of a team that is not just following the standards but setting them.

Duties and Responsibilities:

- Coordinates all movement of controlled substances from receipt, compounding through analytical testing, and dispensing to the end user.
- Trains Empower employees on controlled substances and compliance with Standard Operating Procedures and Work Instructions.
- Implements compliance protocols and procedures to ensure adherence to all applicable laws and regulations.
- Coordinates all controlled substance destruction with appropriate Quality and Logistics departments.
- Remains current on Federal and State laws and regulations to address organizational business needs.
- Identifies opportunities for process improvement and efficiency gains in compliance-related activities.
- Streamlines workflows and procedures to enhance operational effectiveness and maximize compliance outcomes.
- Works closely with cross-functional teams to drive compliance initiatives and foster a culture of continuous improvement.
- Collaborates with stakeholders to implement innovative solutions and best practices in compliance management.
- Conducts regular audits in various departments to oversee process flows and ensure adherence to standard operating procedures in addition to state and federal laws and regulations.
- Conduct regular audits on existing provider accounts to ensure adherence and compliance with dispensing restrictions, licensure, state and federal laws and regulations.
- Prepares audit summary reports for review by supervisor.
- May be required to train and assist at Empower’s 503A site as needed.
- Perform other duties as assigned.

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision.

Knowledge and Skills:

- Familiarity with related regulatory matters related to DEA and FDA regulatory compliance, including knowledge of drug compounding, CGMP, State Board of Pharmacy compliance and compliance initiatives.
- Proficient in Microsoft Office (Excel, PowerPoint, etc.).
- Ability to work independently to manage work tasks effectively.
- Must be detail-oriented and possess a high level of accuracy.
- Sensitivity to confidential documents and information.

**Key Competencies**
- Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
- Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
- Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
- Resourcefulness: Secures and deploys resources effectively and efficiently.
- Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
- Ensures Accountability: Holds self and other

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