GMP compliance, Retention control sample management, Water EMP trends investigations, Self-inspections internal Audits, URS DQ IQ OQ PQ protocols, GQS GSOPs implementation, Failure investigation of Unplanned Deviations, Transport Validation activities, Deviations Change Controls CAPAs, Internal External audits

Lean-Six Sigma Black Belt, Project Management

Project Management, Lean Six Sigma

Windows, UNIX, Oracle, data integrity controls, SSAE attestation standards, ICFR, MS SQL Databases, Internal Audit, computer operations controls, Sox Compliance, ITGC’s access controls, COSO, Cobit, AICPA, change management controls, External Audit, Sox

Sql, performance metrics, lean techniques, Six Sigma Black Belt, process improvement

staffing plans , Coaching and Mentoring, Change Six Sigma, Employee Relations