Quality Training Specialist 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.
Position SummaryThe Quality Training Specialist is responsible for the development, coordination, delivery, and maintenance of training programs that support compliance, operational excellence, and employee competency across manufacturing, quality, and compounding. This role ensures training content and delivery methods meet current Good Manufacturing Practice (cGMP) standards, Food and Drug Administration (FDA) regulations, and internal quality system requirements. The Quality Training Specialist partners closely with subject matter experts (SME), operations leaders, and quality teams to ensure employees are trained effectively and aligned with Empower’s mission to deliver safe, affordable, innovative medication.
Duties and Responsibilities- Develops, maintains, and delivers job-specific training programs for sterile and non-sterile manufacturing personnel, compounding technicians, and support staff across 503A and 503B pharmacies.
- Supports the implementation and ongoing maintenance of a robust, compliant training program, including curriculum design, training matrices, qualification protocols, and Learning Management System updates.
- Facilitates onboarding and continued education for staff by coordinating hands-on training, classroom instruction, competency assessments, aseptic technique qualifications, and gowning certifications as applicable.
- Collaborates with Quality Assurance, manufacturing, and SMEs to ensure training materials reflect the most current Standard Operating Procedures, regulatory requirements (e.g., United States Pharmacopeia (USP) 795, 797, 800, FDA, Drug Enforcement Agency), and process updates.
- Assists in internal audits, regulatory inspections, and quality investigations by maintaining accurate training records and identifying training gaps or compliance risks through routine training effectiveness reviews.
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 and Skills- Working knowledge of cGMP, USP 795, 797, 800, and FDA guidelines related to training, manufacturing, and aseptic practices in sterile and non-sterile environments.
- Excellent interpersonal, communication, and presentation skills with the ability to train and influence employees at all levels and translate technical content into clear, engaging instruction.
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 a training, quality assurance, or manufacturing role within a pharmaceutical, compounding, or other cGMP-regulated environment.
- Bachelor’s degree in life sciences, pharmaceutical sciences, education, or a related field preferred; equivalent combination of education and experience may be considered.
- Train-the-Trainer certification, Aseptic Gowning/Technique Trainer qualification, or equivalent instructional certification 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/