Quality Assurance 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.  

This role plays a vital part in ensuring the highest standards of current Good Manufacturing Practices (cGMP) compliance and continuous quality improvement across our manufacturing operations. As a Quality Assurance Specialist focused on site oversight, you will be a key figure in upholding the integrity of our processes and products, helping us deliver safe, consistent, and innovative medications. You will thrive in a mission-driven environment that is expanding access to quality, affordable healthcare, making a real difference in people’s lives.

• Leads routine walkthroughs and quality oversight of compounding and manufacturing areas to ensure compliance with Food and Drug Administration, United States Pharmacopeia, and internal standards.
• Collaborates cross-functionally with site business units and regulatory teams to support deviation investigations, conduct risk assessments, and implement corrective and preventive actions resulting from internal or external audits.
• Maintains detailed and accurate quality records in accordance with regulatory requirements, internal policies and enterprise Quality Assurance oversight, ensuring timely closure and archiving of all documents.
• Conducts internal audits, prepares inspection readiness documentation, and supports regulatory inspections to ensure operational readiness.
• Supports training efforts to reinforce quality culture and adherence to evolving regulatory expectations and internal quality metrics.

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.

• Exceptional attention to detail, collaborative mindset, and strong communication skills to influence cross-functional stakeholders and build a culture of quality excellence.
• Proficiency in reviewing documentation for accuracy, understanding batch record flow, and knowledge of root cause analysis tools; working knowledge of Microsoft Office tools required.

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 3 years of experience in Quality within pharmaceutical manufacturing, with a strong understanding of cGMP and regulatory compliance.
• Requires a Bachelor’s degree in life sciences, pharmaceutical sciences, or a related discipline or equivalent work experience.
• Certified Quality Auditor (CQA); Certified Quality Improvement Associate (CQIA) strongly 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/