Compliance Specialist (503A & 503B)

Empower Pharmacy•Houston, TX

2d•Onsite

About The Position

Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the nation’s most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we’re redefining what’s possible in personalized medicine and pharmaceutical manufacturing. We’re 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 is built on four core values: People, Quality, Service, and Innovation. Guided by these principles, we’ve created a uniquely integrated healthcare platform powered by advanced technology, operational excellence, and a relentless commitment to patient care. From manufacturing and quality control to distribution and customer experience, our teams work together to raise industry standards, expand access to critical medications, and improve outcomes for patients and providers across the country. At Empower, joining our team means more than starting a new role. It means becoming part of a mission-driven organization that’s transforming healthcare at scale. We invest deeply in our people, encourage bold thinking, and create opportunities for growth, leadership, and innovation at every level. Your ideas matter here, your development is supported, and the work you do has a direct impact on the lives of millions. If you thrive in a fast-moving, purpose-driven environment where innovation, collaboration, and ambition come together, Empower Pharmacy is the place for you. Let’s transform healthcare together. POSITION 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.

Requirements

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.
Bachelor’s degree in a related field required; advanced degree preferred.
Minimum of 5 years of compliance experience within regulated industries.
Proven ability to support regulatory interactions and cross-functional stakeholder engagement.

Nice To Haves

Experience with AI technologies and data analysis tools in compliance-related functions preferred.
Texas Certified Pharmacy Technician certification preferred.

Responsibilities

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.
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.
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.
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.
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.
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.
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.