Compliance Specialist (503A & 503B)
Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility serving the functional medicine markets, we are proud to be recognized as one of Houston’s fastest-growing private companies and ranked #116 in Healthcare & Medical on the Inc. 5000 List for 2025.
Our strength lies in four core values—People, Quality, Service, and Innovation. Guided by these principles, we deliver a uniquely integrated approach to healthcare through vertical supply chain integration, advanced technology, and a relentless pursuit of excellence. From manufacturing to distribution to quality control, our teams work collaboratively to push boundaries, improve patient outcomes, and redefine medication accessibility.
At Empower, joining our team means more than starting a new job, it means becoming part of a mission to transform healthcare. We empower our employees to innovate, grow, and make a meaningful impact every day. Here, your ideas are valued, your growth is supported, and your contributions are celebrated.
If you thrive in a fast-paced, transformative environment where innovation meets purpose, Empower Pharmacy is the place for you. Let’s revolutionize healthcare together.
Positions Summary:
The Compliance Specialist (503A & 503B) supports and maintains Empower’s regulatory compliance programs across both pharmacy (503A) and outsourcing facility (503B) operations. This role ensures adherence to DEA, FDA, USP, and State Board of Pharmacy requirements through auditing, process monitoring, training, and cross-functional collaboration.
Acting as a key operational partner to Compliance leadership, this position supports inspection readiness, reinforces procedural compliance, and contributes to continuous improvement initiatives that reduce risk and strengthen regulatory alignment. The role plays a critical part in maintaining controlled substance accountability, audit integrity, and sustainable compliance within a highly regulated, high-growth environment.
Success in this role is measured by audit effectiveness, process accuracy, reduction in deviations, and the ability to maintain inspection-ready operations across both 503A and 503B environments.
Responsibilities:
Controlled Substance Compliance & Operational Oversight
- Monitor the movement of controlled substances through receipt, compounding, testing, dispensing, and destruction while ensuring compliance with DEA regulations and internal procedures.
- Support accurate documentation, reconciliation, and reporting processes to maintain traceability and prevent discrepancies.
- Assist with Prescription Monitoring Program (PMP) compliance, including submissions, corrections, and voids.
Compliance Auditing & Inspection Readiness
- Conduct internal audits to evaluate adherence to federal and state regulations, SOPs, and operational processes across 503A and 503B operations.
- Prepare audit reports, track findings, and support timely resolution of corrective actions.
- Support inspection readiness activities by organizing documentation, assisting with mock audits, and maintaining required records.
Training & Procedural Compliance
- Train employees on compliance requirements, including controlled substance handling, SOP adherence, and regulatory expectations.
- Support implementation and reinforcement of compliance protocols and work instructions.
- Collaborate cross-functionally to ensure consistent understanding and execution of compliance standards.
Regulatory Monitoring & Process Improvement
- Remain current on FDA, DEA, USP, and State Board regulations, identifying operational impacts and compliance requirements.
- Support continuous improvement initiatives by identifying process gaps, inefficiencies, and compliance risks.
- Assist in implementing updated procedures and controls aligned with evolving regulatory expectations.
Cross-Functional Collaboration & Project Support
- Partner with internal stakeholders to streamline workflows and improve compliance-related processes.
- Coordinate compliance-related activities and support project tracking for regulatory initiatives.
- Provide support across Empower locations or shifts as needed to maintain continuity of compliance operations.
Compliance Documentation & Reporting
- Maintain accurate compliance records, including audit documentation, training records, and controlled substance logs.
- Support reporting of compliance metrics, audit trends, and operational risks.
- Handle confidential information in accordance with company policies and regulatory requirements.
AI-Enabled Compliance & Operational Efficiency
- Leverage AI tools to support regulatory research, streamline documentation, and improve accuracy in compliance workflows.
- Support automated tracking tools and dashboards for licenses, audits, CAPAs, and inspection readiness activities.
- Utilize data insights to identify trends, improve reporting visibility, and support proactive risk management.
Knowledge and Skills:
- Working knowledge of 503A and 503B regulatory frameworks, USP 795/797/800 standards, FDA guidance, DEA requirements, and State Board of Pharmacy regulations.
- Experience supporting compliance activities including internal audits, documentation review, and adherence to SOPs and regulatory requirements.
- Ability to assist with CAPA tracking, root cause analysis, and regulatory response support.
- Familiarity with AI and technology tools used to streamline documentation, research, and compliance operations.
- Strong organizational skills and attention to detail with a process-driven mindset.
Experience and Qualifications:
- Bachelor’s degree in a related field required; advanced degree preferred.
- Minimum of 5 years of compliance experience within regulated industries.
- Experience with AI technologies and data analysis tools in compliance-related functions preferred.
- Proven ability to support regulatory interactions and cross-functional stakeholder engagement.
- Texas Certified Pharmacy Technician certification preferred.
Key Competencies:
- Customer Focus: Builds trust through customer-centric solutions
- Strategic AI: Guides responsible AI adoption and adaptation
- Optimizes Work Processes: Drives efficiency with continuous improvement
- Collaborates: Partners effectively to achieve shared goals
- Resourcefulness: Secures and deploys resources efficiently
- Manages Complexity: Simplifies and solves complex challenges
- Ensures Accountability: Delivers on commitments with integrity
- Situational Adaptability: Adjusts approach to shifting conditions
- Communicates Effectively: Tailors messages to diverse audiences
Values:
- People: Empowering people defines who we are
- Quality: Excellence in every product, every time
- Service: Serving others is our highest purpose
- Innovation: Advancing care through technology and discovery
Employee Benefits, Health, and Wellness:
We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/
Physical Requirements:
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 in order to access, input, and retrieve information from the computer and other office productivity devices. Employees are 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.