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503B Jobs in Texas (NOW HIRING)

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Visual Inspection Clerk

Irving, TX · On-site

$15.75 - $19.25/hr

- Visual Inspection Clerk (503B Compounding Industry) Position Summary The Visual Inspection (VI) Clerk supports the quality assurance and production teams in the inspection, documentation, and ...

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503B information

What is a 503B facility?

A 503B facility refers to an outsourcing pharmacy registered with the U.S. Food and Drug Administration (FDA) under section 503B of the Federal Food, Drug, and Cosmetic Act. These facilities are allowed to compound large batches of medications, typically sterile drugs, in advance of receiving prescriptions, and can distribute them to healthcare facilities nationwide. 503B facilities must adhere to strict quality standards and are subject to regular FDA inspections to ensure safety and compliance. This designation helps hospitals and clinics obtain ready-to-use compounded medications, especially during drug shortages.

What are the key skills and qualifications needed to thrive as a 503B outsourcing facility pharmacist, and why are they important?

To thrive as a 503B Outsourcing Facility Pharmacist, you need a Doctor of Pharmacy (PharmD) degree, state licensure, and expertise in sterile compounding and current Good Manufacturing Practices (cGMP). Familiarity with compounding automation systems, environmental monitoring tools, and regulatory compliance software is crucial. Attention to detail, strong organizational skills, and effective communication are vital soft skills for ensuring operational efficiency and regulatory adherence. These competencies are essential to maintain product safety, regulatory compliance, and high-quality pharmaceutical production in a highly regulated environment.

What are some common challenges faced by professionals working in a 503B outsourcing facility?

Professionals in 503B outsourcing facilities often encounter challenges related to maintaining strict compliance with FDA regulations, especially regarding Current Good Manufacturing Practice (cGMP) standards. The work environment is highly regulated, requiring meticulous documentation and quality assurance to ensure patient safety. Additionally, there may be frequent audits and inspections, which require staff to stay up-to-date with evolving regulatory requirements. Collaboration with quality assurance, regulatory, and pharmacy teams is essential to address compliance issues and improve operational efficiency.

What is the difference between 503B vs 503A?

Aspect503B503A
CertificationsPharmacist, FDA compliancePharmacist, state board licensing
Work EnvironmentOutsourced sterile compounding facilitiesIn-house pharmacy compounding
Regulatory OversightFDA regulatedState pharmacy boards
Industry UsageLarge-scale, outsourcing pharmaciesCommunity and hospital pharmacies

503B facilities operate under FDA regulations, focusing on large-scale sterile compounding outside traditional pharmacies, often serving multiple healthcare providers. In contrast, 503A pharmacies are typically local, in-house pharmacies complying with state pharmacy laws. Both roles require pharmacy credentials but differ mainly in regulatory oversight and operational scope.

How to become a 503B?

A 503B refers to a compound outsourcing facility registered with the FDA that compiles with Good Manufacturing Practices. To become a 503B, a facility must register with the FDA, comply with quality standards, and often employ licensed pharmacists and qualified personnel. For individuals, working in a 503B facility typically requires relevant pharmaceutical or healthcare experience and certifications such as pharmacy licensure or quality assurance training.

What cities in Texas are hiring for 503B jobs?

Cities in Texas with the most 503B job openings:

Infographic showing various 503B job openings in Texas as of August 2026, with employment types broken down into 91% Full Time, 6% Part Time, 1% Contract, and 2% Nights. Highlights an 79% Physical, 1% Hybrid, and 20% Remote job distribution.

Compliance Specialist (503A & 503B)

Empower Pharmacy

Houston, TX • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 15 days ago


Empower Pharmacy rating

8.3

Company rating: 8.3 out of 10

Based on 17 frontline employees who took The Breakroom Quiz

12th of 113 rated pharmacies


Job description

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.
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.

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