High School Diploma or GED and 8+ years of experience, or Associate's degree with 6+ years of experience, or Bachelor's degree from an accredited university and 4+ years of experience, or Master's degree and 2+ years of experience is required
QC experience in a pharmaceutical or related (regulated) environment required
Experience with computerized laboratory systems (iStability, Global LIMS, etc.) preferred
Demonstrated expert understanding of processes, procedures & products associated with assigned areas required. Able to perform detailed analysis of events & processes, develop appropriate responses to situational needs, & convey information/results to various organizational levels as appropriate required
Demonstrated knowledge of adult learning methodologies & is able to use multiple methods to train & coach others within the department & organization preferred
Excellent verbal & written communication skills, investigative writing skills, & computer skills required (MS Word, Outlook, Excel, PowerPoint, Global LIMS, iStability and Microsoft Project)
Demonstrated experience in practical problem solving & process improvement methods required
Demonstrated ability to manage multiple tasks/deadlines & prioritize properly based on process needs & events. Demonstrated effectiveness in systematic follow-up required
Understand the processes and products at an advanced level required
Demonstrates understanding of project management and NN gate process flow preferred
Expert level of knowledge & understanding regarding departmental SOP’s & their high-level inter-relationships required (i.e. how they work together to establish a system)