Quality Investigator

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 OVERVIEW: The Quality Investigator provides dedicated ownership of complex nonconformance investigations at Empower’s 503A site within a hyper-growth, highly regulated 503A/503B organization. This individual contributor gathers evidence, conducts root cause analysis, and writes clear, consistent investigation reports that support timely closure and appropriate corrective and preventive actions. The role partners with Quality and operational stakeholders to resolve documentation gaps, maintain investigation progress, and prevent backlog recurrence. Success requires sound judgment, disciplined execution, and the ability to translate complex technical information into defensible conclusions without compromising product quality or patient safety. By identifying recurring issues, strengthening investigation documentation, and adapting to evolving procedures and priorities, the Quality Investigator builds sustainable internal capability, reduces reliance on temporary support, and helps Empower maintain reliable operations as demand and organizational complexity continue to grow. RESPONSIBILITIES: Investigation Execution Evidence Review: Gather and evaluate relevant records and stakeholder input to establish clear event timelines, investigation scope, and documented facts. Root Causes: Analyze complex nonconformances, distinguish contributing factors from root causes, and substantiate conclusions with evidence rather than unsupported assumptions. Investigation Writing: Draft complete, technically accurate investigation reports that connect nonconformance details, supporting evidence, root causes, and proposed corrective actions. Closure and Backlog Control Case Ownership: Manage assigned investigations through documentation and review, resolve reviewer comments, and coordinate outstanding inputs to support timely closure. Backlog Prevention: Track investigation aging, prioritize work by risk and due dates, and escalate barriers before unresolved cases accumulate. Corrective Actions: Partner with process owners to develop corrective and preventive actions that address documented root causes and support recurrence prevention. Quality and Collaboration Regulated Documentation: Apply site procedures and applicable USP requirements to investigation documentation, escalating product quality or patient safety concerns promptly. Stakeholder Alignment: Present investigation findings to Quality and operational stakeholders, explain supporting rationale, and resolve technical questions to support informed decisions. Process Improvement: Identify recurring investigation and documentation issues, recommend process improvements, and share practical writing guidance to strengthen internal investigation capability. KNOWLEDGE AND SKILLS: Proficiency in technical writing and Microsoft Word and Excel to organize investigation evidence, develop clear narratives, and maintain accurate progress tracking. Working knowledge of root cause analysis and corrective and preventive action methods, with disciplined evaluation of evidence and contributing factors. Knowledge of applicable USP standards, including USP 795, 797, and 800, and site procedures governing compounding quality and investigation documentation. Ability to prioritize concurrent investigations, communicate technical findings across functions, resolve information gaps, and escalate risks while maintaining documentation accuracy. EXPERIENCE AND QUALIFICATIONS: 3 years of experience in quality assurance or quality control, including independently writing complex investigations, conducting root cause analysis, and supporting corrective actions required. Bachelor’s degree in science or a related field, or an equivalent combination of relevant education and practical investigation experience required. Demonstrated success managing concurrent investigations, meeting documentation deadlines, and coordinating technical input from multiple stakeholders in a regulated operating environment required. Experience supporting pharmaceutical or compounding investigations, improving investigation documentation, and reducing or preventing backlogs through consistent follow-through and process improvement 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.