Quality Operations Specialist 503B (1st shift)

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 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.

Requirements

Minimum of 4 years of directly related experience.
Bachelor of Science in a science-related discipline required.
Strong attention to detail, organizational, and prioritization skills.
Proficiency in Microsoft Office, including Excel, Word, PowerPoint, and Outlook.
Experience in sterile and non-sterile manufacturing and knowledge of state and federal regulations required.
Strong knowledge of cGMP regulations, sterile and non-sterile manufacturing processes, and quality systems.
Proficiency in data analysis, root cause investigation methodologies, and CAPA processes.
Strong organizational, prioritization, and multitasking skills in fast-paced, regulated environments.
Effective communication and cross-functional collaboration skills.

Responsibilities

Conduct detailed review of cGMP batch records and manufacturing documentation, using AI-enabled validation tools to identify discrepancies, improve accuracy, and accelerate throughput.
Monitor manufacturing activities to ensure adherence to aseptic techniques, cleanroom standards, and operational procedures.
Support product release readiness by verifying data integrity and completeness while ensuring alignment with regulatory expectations and quality standards.
Identify, document, and support triage of deviations, ensuring timely escalation and compliance with internal procedures and regulatory requirements.
Perform structured root cause analysis using data-driven methodologies to uncover underlying issues and support effective corrective actions.
Assist in the development and implementation of corrective and preventive actions, tracking effectiveness and closure.
Execute quality processes in alignment with FDA and state regulations within a 503A/503B environment.
Perform and support environmental monitoring activities to ensure compliance with sterility and contamination control standards.
Collaborate with cross-functional teams to resolve quality issues, improve workflows, and support high-quality execution.