Quality Engineer II 503B

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 Quality Engineer II ensures compliance with United States Pharmacopeia (USP), Food and Drug Administration (FDA), and Current Good Manufacturing Practice (cGMP) standards through audits, inspections, and process evaluations. This role leads investigations, implements Corrective and Preventive Actions (CAPAs), and collaborates across teams to enhance quality systems and drive continuous improvement.

• Ensures compliance with compounding practices, USP, FDA, and cGMP through audits, inspections, and evaluations of deviations, complaints, and CAPAs.
• Develops processes and documentation per cGMP, reviewing change controls and quality records.
• Leads investigations of deviations and complaints, implementing CAPAs using root cause analysis, and collaborates with teams to improve quality systems and provide compliance training.
• Reviews and approves tech transfer protocols, change controls, and quality records in the electronic Document Control System.
• Conducts risk assessments to address quality issues, drive improvements, and support inspection readiness and audits.

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.

• Knowledge of product investigations, CAPA, document and change control, and cGMP regulations, including USP <795>, <797>, <800>, and 21 Code of Federal Regulations Parts 210, 211, and 11, with experience in sterile and aseptic manufacturing.
• Strong communication skills, cross-functional collaboration, and proficiency in Six Sigma, lean manufacturing, Microsoft Office, and data analysis tools like Excel or Minitab.

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 pharmaceutical industry experience, including qualification protocols, validations, root cause analysis, compendial testing, and knowledge of FDA regulations and cGMP standards required.
• Bachelor’s degree in a science or engineering technical field.

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/