Compliance Specialist 503B

Houston, TX, United States

Company Overview

Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.

What sets us apart is our relentless focus on three core values: People, Quality and Service. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.

You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you’ll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.

Let’s revolutionize healthcare, together. Join us and be a part of something extraordinary.

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 accountable to meet commitment.

Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.

Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Experience and Qualifications

High school degree required, bachelor's degree in pharmacy, healthcare administration, or related field preferred.

3 to 5 years of relevant work experience in place of degree required.

Experience implementing and maintaining compliance systems preferred.

Employee Benefits, Health, and Wellness

No-Cost Medication : Get your prescribed compounded medications at no cost, ensuring your health without the financial burden

Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels

Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family

Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family

Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off

Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions

Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance

FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA)

401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%

Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time

Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options

Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck

Additional Voluntary Benefits

Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury

Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays

Critical Illness: Protect your finances from the expenses of a serious health issue

Short-Term Disability: Protect your income during illness or injury with short-term disability coverage

Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage

Legal Services: Access professional legal assistance to address concerns confidently

Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit

Pet Insurance: Care for your furry family members with our pet insurance coverage

Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being

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