QO Investigations Coordinator 503B

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 QO Investigations Coordinator supports product integrity and compliant quality operations by coordinating investigation activities, maintaining accurate records, and advancing timely resolution of quality events. Working within Empower’s hyper-growth, highly regulated 503A and 503B environment, this role supports investigations involving deviations, non-conformances, and laboratory or production events while aligning documentation with USP standards, cGMP requirements, and established procedures.

The coordinator gathers and analyzes data, assists with root cause analysis, tracks corrective and preventive actions, and prepares metrics that highlight recurring issues and improvement opportunities. Success requires disciplined execution, sound judgment, strong organization, clear communication, and learning agility.

The role contributes directly to investigation quality, documentation accuracy, CAPA follow-through, operational visibility, continuous improvement, and strong execution consistency while helping protect product quality, patient safety, and regulatory readiness across daily quality operations.

RESPONSIBILITIES

Investigation Support

• Data Collection: Collect and organize investigation data for deviations, non-conformances, and laboratory or production events to support accurate, evidence-based assessments.
• Initial Assessment: Conduct initial event assessments using approved templates and guidance, documenting relevant facts, observations, and potential contributing factors clearly.
• Investigation Writing: Draft investigation documentation that accurately summarizes evidence, analysis, conclusions, and follow-up requirements in accordance with established procedures.

CAPA and Documentation

• CAPA Tracking: Track corrective and preventive action commitments, due dates, and follow-up activities to support timely, complete implementation across responsible functions.
• Record Maintenance: Maintain complete investigation records and supporting documentation, ensuring information remains organized, traceable, current, and aligned with procedural requirements.
• Compliance Support: Apply cGMP and applicable USP <795>, USP <797>, and USP <800> requirements when documenting investigations and coordinating quality follow-up activities.

Collaboration and Improvement

• Team Coordination: Collaborate with Quality leadership and cross-functional partners to gather information, resolve documentation gaps, and advance investigations toward timely closure.
• Trend Reporting: Compile investigation metrics and trending reports that identify recurring issues, emerging patterns, and practical opportunities for continuous improvement.
• Issue Escalation: Escalate missing information, overdue actions, or investigation barriers promptly, enabling Quality leadership to address risks and maintain execution discipline.

KNOWLEDGE AND SKILLS

• Working knowledge of quality investigation practices, including data collection, event documentation, root cause support, CAPA tracking, and investigation record maintenance.
• Understanding of cGMP requirements and USP <795>, USP <797>, and USP <800> standards as applied to quality documentation and investigation activities.
• Strong analytical, organizational, and time management skills for compiling accurate data, tracking follow-up actions, and managing multiple investigation priorities.
• Proficiency with Microsoft Excel and Word, plus the ability to navigate investigation tracking systems and prepare clear, accurate quality reports.

EXPERIENCE AND QUALIFICATIONS

• Minimum of two years of Quality Assurance or Quality Control experience within a pharmaceutical or healthcare environment, including investigation or documentation exposure.
• Associate degree in a scientific or technical discipline, or an equivalent combination of education and regulated manufacturing or health science experience.
• Demonstrated ability to collect, analyze, and document quality data accurately while following established procedures and supporting investigation timelines.
• Strong written communication, attention to detail, organization, and cross-functional coordination skills in a regulated, documentation-driven work environment.
• Experience supporting deviations, non-conformances, CAPAs, trending reports, or investigation tracking within pharmaceutical manufacturing or another regulated quality setting preferred.
• Certified Quality Improvement Associate (CQIA) 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.