Labeling & Release 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.
Position SummaryThe Labeling & Release Coordinator is a technical role responsible for the final inspection, labeling, and release preparation of compounded pharmaceutical products. This individual ensures label accuracy, visual quality, documentation compliance, and equipment readiness in accordance with Empower Pharmacy’s commitment to quality and regulatory excellence. The position serves as a crucial link between Production and Quality teams, directly supporting product readiness for patient use.
Duties and Responsibilities- Independently manages the full specialty labeling process, including editing, printing, and precise manual application using the Quick Label system, ensuring all labels accurately reflect lot numbers, beyond-use dates, product strength, and required regulatory information.
- Conducts detailed visual inspections of finished non-sterile compounded products to identify labeling errors, contamination, or leftover materials, ensuring each product meets internal quality standards before release.
- Reviews and verifies labeling documentation such as weight sheets, batch records, and product logs, resolving discrepancies to maintain traceability and compliance with Food and Drug Administration (FDA) and United States Pharmacopeia standards for non-sterile and hazardous drug compounding.
- Supports investigations into labeling or packaging deviations, contribute to root cause analysis and corrective actions, and collaborate on improving procedures and drafting standard operating protocols (SOP) that align with regulatory expectations.
- Acts as a subject matter expert by training team members, promoting best practices in inspection and documentation, and coordinating with Production, Quality Assurance (QA), Research and Development, and Regulatory teams to maintain label accuracy through process updates.
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 to access, input, and retrieve information from the computer and other office productivity devices. Employees are 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- Ability to inspect finished products for visual quality, labeling accuracy, and contamination risks, ensuring release-readiness and alignment with weight sheets, logs, and SOPs.
- Proficient in label design and printing systems (e.g., Quick Label), with strong attention to detail, critical thinking skills, and experience supporting investigations, corrective and preventive action plans, or SOP enhancements in a regulated environment.
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 in nonsterile compounding, production, or quality control, with demonstrated expertise in product release processes, label reconciliation, and batch documentation review in compliance with USP <795>/<800> and FDA standards.
- High school diploma or equivalent required; Associate’s degree in pharmaceutical sciences, QA, or a related field preferred, with a solid understanding of Good Documentation Practices and regulatory protocols.
- Certified Pharmacy Technician (CPhT) required; Pharmacy Technician Certification Board (PTCB) Technician Product Verification (TPV) and Lean Six Sigma White Belt (LSSWB) 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/