Quality Operations Specialist 503B (1st shift)
Empower Pharmacy
| Company | Empower Pharmacy |
| Category | Operations & Admin |
| Location | Houston |
| Remote | On-site (inferred) |
| Employment | Not stated |
| Level | Not stated |
| Salary | Not stated by the employer |
| Posted | 1 May 2026 |
| Last verified | 12 Aug 2026 |
| Source | Employer ATS (greenhouse) |
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 Quality Operations Specialist ensures consistent delivery of safe, sterile, and compliant pharmaceutical products, directly impacting patient outcomes and regulatory standing. This role owns quality oversight across manufacturing review, deviation management, and compliance assurance within a fast-scaling 503A/503B environment. Leveraging AI as a force multiplier, the Specialist enhances review speed, improves deviation detection, strengthens root cause analysis, and enables data-driven decision-making at scale. Operating with high autonomy, this role integrates quality into operational execution while continuously improving systems and processes.
Responsibilities:
Quality Execution
Batch Review: Conduct detailed review of cGMP batch records and manufacturing documentation, using AI-enabled validation tools to identify discrepancies, improve accuracy, and accelerate throughput.
Process Monitoring: Monitor manufacturing activities to ensure adherence to aseptic techniques, cleanroom standards, and operational procedures.
Release Support: Support product release readiness by verifying data integrity and completeness while ensuring alignment with regulatory expectations and quality standards.
Deviation and Investigation
Deviation Handling: Identify, document, and support triage of deviations, ensuring timely escalation and compliance with internal procedures and regulatory requirements.
Root Cause Analysis: Perform structured root cause analysis using data-driven methodologies to uncover underlying issues and support effective corrective actions.
CAPA Support: Assist in the development and implementation of corrective and preventive actions, tracking effectiveness and closure.
Compliance and Efficiency
Regulatory Adherence: Execute quality processes in alignment with FDA and state regulations within a 503A/503B environment.
Environmental Monitoring: Perform and support environmental monitoring activities to ensure compliance with sterility and contamination control standards.
Operational Support: Collaborate with cross-functional teams to resolve quality issues, improve workflows, and support high-quality execution.
Knowledge and Skills:
Strong knowledge of cGMP regulations, sterile and non-sterile ma