Microbiologist III

Empower Pharmacy

Location
Houston, TX
Employment type
unknown
Posted
Posted
  • Quality

About the role

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 Microbiologist III 503A serves as a senior technical contributor supporting product quality, patient safety, and microbiological control within Empower’s 503A compounding operations. The role independently performs and reviews complex testing, leads laboratory and contamination investigations, and owns assigned microbiology projects through completion. This position provides technical guidance to Microbiologists I and II, strengthens environmental monitoring and contamination control practices, and translates laboratory trends into actionable recommendations. Working with Quality, Production, Engineering, and Validation, the Microbiologist III resolves complex issues and supports scientifically sound quality decisions. The role may also support 503B activities as assigned under applicable site procedures and requirements. RESPONSIBILITIES Microbiology Operations Advanced testing and technical review: Independently perform and troubleshoot microbiological testing, environmental monitoring, growth promotion, and sample analysis. Review laboratory records and results for scientific accuracy, completeness, data integrity, and adherence to approved procedures within delegated authority. Laboratory and workflow ownership: Coordinate testing priorities, sample tracking, equipment readiness, media controls, inventory, and calibration activities. Resolve technical obstacles, communicate risks to turnaround times, and escalate resource or quality concerns before they affect operations. Quality and Compliance Investigation leadership: Lead complex microbiological deviations, environmental excursions, out-of-specification and out-of-trend investigations, and contamination events. Define investigation plans, assess laboratory and operational evidence, identify root causes, and document scientifically supported conclusions. Evaluate potential product and process impact with Quality and escalate patient safety concerns promptly. Corrective and preventive actions: Develop corrective and preventive actions with accountable owners, completion dates, and effectiveness criteria. Track assigned actions to closure, verify that controls address root causes, and identify recurring issues requiring broader remediation. Environmental monitoring and contamination control: Serve as a technical resource for monitoring plans, sampling practices, recovery patterns, and contamination prevention. Analyze trends by location, organism, personnel, and process, as applicable. Recommend justified changes to monitoring, cleaning, disinfection, gowning, and aseptic practices through approved change controls. Technical Leadership and Continuous Improvement Methods and laboratory improvements: Lead assigned method suitability, verification, validation, or transfer activities as appropriate to the method and intended use. Draft protocols, evaluate acceptance criteria and results, and prepare reports for approval. Troubleshoot recurring method or equipment issues and coordinate implementation with Quality and Validation. Training and mentoring: Train and mentor Microbiologists I and II in laboratory methods, aseptic technique, documentation, investigations, and troubleshooting. Assess proficiency within assigned authority, provide timely coaching, and promote consistent execution across the team. Cross functional project leadership: Lead microbiology workstreams for process changes, new equipment, facility improvements, and operational expansion. Evaluate microbiological risks, define technical deliverables, and coordinate activities with Quality Assurance, Production, Engineering, and Validation. KNOWLEDGE AND SKILLS Advanced knowledge of microbiological testing, environmental monitoring, aseptic processing, contamination control, and the quality requirements applicable to assigned compounding and laboratory activities. Ability to interpret complex microbiological data, distinguish laboratory error from process-related contamination, assess risk, and develop scientifically defensible investigation conclusions and corrective actions. <span data-ccp-props="{"201341983":0,"335559

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