Quality Operations Specialist 503B (2nd Shift)

Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility serving the functional medicine markets, we are 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 lies in four core values—People, Quality, Service, and Innovation. Guided by these principles, we deliver a uniquely integrated approach to healthcare through vertical supply chain integration, advanced technology, and a relentless pursuit of excellence. From manufacturing to distribution to quality control, our teams work collaboratively to push boundaries, improve patient outcomes, and redefine medication accessibility. At Empower, joining our team means more than starting a new job, it means becoming part of a mission to transform healthcare. We empower our employees to innovate, grow, and make a meaningful impact every day. Here, your ideas are valued, your growth is supported, and your contributions are celebrated. If you thrive in a fast-paced, transformative environment where innovation meets purpose, Empower Pharmacy is the place for you. Let’s revolutionize 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