The Quality Operations Specialist ensures product safety and sterility through oversight, documentation review, and issue resolution, supporting Empower’s mission to provide affordable, innovative medications.

• Oversees manufacturing operations to ensure product sterility, safety, and quality, monitoring personnel and processes with authority to halt operations if needed.
• Reviews Current Good Manufacturing Practice (cGMP) batch records and documentation for accuracy, ensuring compliance with procedures and standards.
• Assists in investigations to identify root causes, implement corrective actions, and resolve quality issues using problem-solving skills.
• Conducts operational checks on cleaning, labeling, and cleanroom layouts, ensuring compliance with environmental monitoring and documentation standards.
• Supports safety, improvement initiatives, and serves as backup for Environmental Monitoring Technician tasks, including gown qualification and media fill proctoring.

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.

• Strong attention to detail, organizational, and prioritization skills, with the ability to multitask effectively while adhering to aseptic and regulatory standards.
• Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook) with required experience in sterile and nonsterile manufacturing and knowledge of state and federal regulations.

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 4 years of directly related experience in lieu of the degree requirement required OR
• Bachelor of Science in a science-related discipline.

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/