Position Summary:
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:
Key Competencies
Values
The Quality Operations Technician plays a critical role in ensuring that Empower’s compounding operations consistently meet the highest standards of safety, quality, and compliance. This position provides the opportunity to be part of a dynamic team committed to advancing the production of innovative medications that help people live healthier, happier lives. By supporting quality management systems and regulatory compliance, you’ll directly contribute to Empower's mission of expanding access to affordable, high-quality medications.
Duties and Responsibilities:
- Monitors and ensures adherence to current Good Manufacturing Practices (cGMP) and regulatory standards across all quality operations, including documentation, processes, and equipment, to maintain the highest quality and safety standards in a 503A and 503B compounding environment.
- Assists in the execution of batch record reviews, ensuring all documentation is accurate, complete, and compliant with regulatory requirements, and works to resolve discrepancies to prevent delays in production.
- Coordinates and performs routine inspections and testing of equipment, environments, and systems to ensure they meet required standards, facilitating timely corrective actions when necessary.
- Collaborates with cross-functional teams to support continuous improvement initiatives, analyzing quality trends and identifying areas for process optimization to enhance overall operational efficiency and product quality.
- Supports the training and development of staff on quality control procedures, ensuring the team is well-equipped to uphold rigorous standards, troubleshoot issues, and implement best practices across all stages of production.
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.
- Good attention to detail, problem-solving, and organizational skills, with the ability to collaborate across departments and ensure adherence to quality and regulatory standards while fostering a culture of continuous improvement.
- Proficiency in quality management systems, documentation practices, and regulatory compliance standards, with basic knowledge of laboratory equipment, environmental monitoring, and 503A and 503B 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 1 year of experience in quality operations, quality control, or regulatory compliance within a pharmaceutical or healthcare environment, with a focus on cGMP and compounding operations preferred.
- Requires a Bachelor’s degree in life sciences, chemistry, or a related 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/
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