Complaint Handling Specialist 503A

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 Complaint Handling Specialist ensures prompt resolution of complaints, compliance with regulations, and quality improvement, supporting Empower Pharmacy’s mission to deliver affordable, innovative medications.

• Manages customer complaints, product quality investigations, and Adverse Drug Event (ADE) reporting, ensuring data is tracked, trended, and resolved promptly.
• Oversees and maintains Standard Operating Procedures (SOPs) while ensuring all documentation complies with state and federal requirements, including Food and Drug Administration (FDA) reporting and follow-up.
• Tracks and integrates complaint trends into quality reviews such as Biannual Product Reviews and non-compliance incidents to drive continuous improvement.
• Assists with clinical and product inquiries, promptly identifying and resolving quality issues while adhering to safety and regulatory guidelines.
• Collaborates with cross-functional teams on projects and duties to support product quality and process improvement initiatives.

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.

• Requires knowledge of pharmaceutical manufacturing, United States Pharmacopeia (USP), and current Good Manufacturing Practices (cGMP), with strong technical writing and problem-solving skills.
• Proficiency in quality management software and Microsoft Office is essential; experience in 503A or 503B facilities is a plus.

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.

• Minimum of 2 years of experience with sterile drug manufacturing operations is required.
• Bachelor’s degree in a technical or scientific discipline or equivalent experience is required.

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/