Pharmaceutical Operations Specialist

Pay Competitive

Location Houston/Texas

Employment type

Full-Time

Req#: 1952 Company Overview

Empower Pharmacy and Empower Pharma are the country's most advanced compounding pharmacy and FDA-registered outsourcing facility, providing pharmacies, healthcare practitioners and patients with personalized pharmaceuticals in the integrative health and wellness market. We currently serve more than 3.5 million patients across the United States.

With facilities that tout the latest automated pharmaceutical manufacturing equipment, clean rooms, environmental controls and professional staff, we are proud of our leadership in the compounding industry. How we work is just as important as the work we do. We know that the basis of a great company is our people. Our diverse culture is the foundation for our growing company’s broader perspective: to serve the needs of our patients through innovation.

We are always seeking new ways to advance the manufacture and distribution of quality-of-life products through cutting-edge processes and technology. Our vision to be the leader in compounding never wavers. With modern, streamlined systems, state-of-the-art facilities and a dedicated team, we strive to deliver access to quality, affordable medication for patients across the country.

Position Summary

The 503A Pharmaceutical Operations Specialist reports to the Manufacturing Specialist Manager and is responsible for executing projects and tasks related to continuous improvement using lean manufacturing principles as well as strategic implementation of upscaling/future projects.

Duties and Responsibilities
• Understands current processes and identify opportunities for improvement, including conducting interviews, observing technicians, collecting data, trending data and analyzing data for improvement
• Performs regular audits of production processes and helps implement lean six sigma manufacturing principles (5S, OSW/SWIs, Gemba, etc.)
• Develops and maintains Standard Operating Procedures (SOPs), Standard Work Instructions (SWIs) and Forms used in both sterile and non-sterile compounding operations
• Works in close collaboration with training and production to develop a robust training program on new processes
• Collaborates with Quality to maintain alignment of manufacturing systems processes with all quality system requirements to improve overall quality of the product
• Identifies areas of waste and improves efficiencies and develop strategies to reduce or eliminate it
• Improves visibility of KPI’s reporting, and development improvement actions based on KPI analysis
• Collaborates with R&D for downstream processing development activities and optimization of manufacturing processes including formulation. Assist if required in the development/optimization of upstream manufacturing processes
• Serves as the SME for details of each specific operation they are supporting
• Provides support to facilitate closure and completion of investigations, deviations and CAPAs (Corrective and Preventative Actions)
• Works closely with quality and engineering teams to help implement new devices, equipment, and processes into production
• Works with the production team to identify areas for process improvement and implement changes to increase efficiency, reduce waste, and improve product quality
• Complies with required PPE while utilizing aseptic technique and minimizing contamination
• Works with cross functional departments to assist in the closure of NCI’s (non-conformance incidents)
• Adapts to and assumes unforeseen responsibilities as the company requires
• Performs other duties as assigned

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.

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…