Compliance Specialist (503A & 503B)

Empower Pharmacy•Houston, TX

2d•Onsite

About The Position

Empower Pharmacy is a leading healthcare company focused on making quality, affordable medication accessible. As a 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we are innovating personalized medicine and pharmaceutical manufacturing. We are recognized as one of Houston's fastest-growing private companies and ranked on the Inc. 5000 List. Our operations are guided by core values of People, Quality, Service, and Innovation, supported by advanced technology and a commitment to patient care. We aim to raise industry standards, expand access to critical medications, and improve patient and provider outcomes. Joining Empower means being part of a mission-driven organization transforming healthcare, with opportunities for growth, leadership, and innovation. We foster an environment where ideas matter, development is supported, and work has a direct impact. If you thrive in a fast-paced, purpose-driven setting that values innovation, collaboration, and ambition, Empower Pharmacy is the place for you.

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.
Experience with AI technologies and data analysis tools in compliance-related functions preferred.
Proven ability to support regulatory interactions and cross-functional stakeholder engagement.

Nice To Haves

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.