Kaleb S.
Manufacturing Quality Supervisor @Otsuka ICU Medical LLC
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WORK HISTORY
Manufacturing Quality Supervisor @Otsuka ICU Medical LLC
Austin, TX, US
As a Manufacturing Quality Supervisor, I lead a team of quality engineers and inspectors dedicated to ensuring our manufacturing processes consistently meet the highest standards of compliance, safety, and operational excellence. In this role, I:•Oversee and guide day-to-day manufacturing operations to maintain strict adherence to GMP and internal procedural requirements.•Conduct real-time reviews of batch records, evaluate equipment logbooks, and perform safety inspections to ensure compliance and operational readiness.•Provide hands-on quality oversight on the production floor, proactively identifying issues and driving timely corrective and preventive actions.•Support CAPA investigations and lead process improvement initiatives with a strong emphasis on quality control and regulatory standards.•Collaborate cross-functionally with production, engineering, and regulatory teams to safeguard product integrity and compliance.•Manage change control documentation and oversee preventive maintenance activities to maintain consistency and reliability in operations.•Supervise, mentor, and develop my team to foster a culture of continuous improvement and sustained quality performance.
EDUCATION
The University of Texas at Austin
Bachelor of Science - BS, Pre-Med, Pre-Dent, Public Health
Temple College
Biology, General
Austin Community College
Associate of Science - AS, Biology, General
ABOUT KALEB S.
With a BS in Public Health from The University of Texas at Austin, my role at ICU Medical is where theory meets practice. Here, problem-solving is not just a skill—it\'s an everyday necessity to maintain FDA compliance and improve manufacturing quality. My education has laid a robust foundation, enabling me to interpret complex data and execute process enhancements within a dynamic healthcare environment.At ICU Medical, collaboration is key; our team\'s efforts are focused on optimizing operations through strategic quality control. It\'s a place where my competencies in presentations and communication truly shine, allowing me to share insights and drive change. As a SEMATF member during my university days, I honed these skills further, preparing me to tackle the challenges of today\'s healthcare industry with confidence and precision.
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