Lehighton, Pennsylvania, United States
Experienced Quality specialist with a demonstrated history of batch review, application of cGMP and ALCOA+ principles, quality compliance, and domestic and international batch release. Proficient in shopfloor audits and walkthroughs, and experienced with lean and agile manufacturing tools. Kata and Gemba leader with regular application of 8-step problem solving. Experienced with learning needs assessments, curriculum design and framework assessments, skills based qualifications, in person and virtual upskilling, and experienced in designing a ground up approach to onboarding new shopfloor employees to expedite their training. Additionally, a paramedic and firefighter with over two decades of prehospital emergency medical and fire suppression experience.