QO Investigations Coordinator

Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.  

What sets us apart is our relentless focus on four core values: People, Quality, Service and Innovation. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.  

You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you’ll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.

Let’s revolutionize healthcare, together. Join us and be a part of something extraordinary.  

The QO Investigations Coordinator plays a vital role in upholding product integrity by supporting investigation activities and compliance with United States Pharmacopeia (USP) and current Good Manufacturing Practices (cGMP) standards. This position is essential to Empower’s mission of expanding access to quality, affordable medication and improving lives through innovative pharmaceutical solutions. The role offers a unique opportunity to contribute meaningfully to quality assurance in a collaborative and mission-driven environment.

• Supports quality investigations by collecting, analyzing, documenting data, and writing investigations related to deviations, non-conformances, and laboratory or production events.
• Conducts initial assessments and supports root cause analysis using approved templates and guidance from Quality leadership.
• Collaborates with cross-functional teams to support timely and complete implementation of Corrective and Preventive Actions.
• Maintains investigation records, tracks follow-up activities, and ensures documentation aligns with established Standard Operating Procedures and regulatory requirements.
• Assists in preparing metrics and trending reports that provide visibility into recurring issues and opportunities for continuous improvement.

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. The employee is 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.

• Detail-oriented and highly organized, with strong time management and communication skills that support effective cross-functional collaboration.
• Proficient in Microsoft Office, particularly Excel and Word, with the ability to navigate investigation tracking systems and compile accurate data and reports in compliance with cGMP, as well as USP 795, 797, and 800 standards.

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Values

• People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.

• A minimum of 2 years of experience in a Quality Assurance or Quality Control setting within a pharmaceutical or healthcare environment, including exposure to investigation or documentation practices.
• Requires an associate degree in a scientific or technical discipline, or equivalent work experience in a regulated manufacturing or health science work environment.
• Certified Quality Improvement Associate (CQIA) preferred.

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/