Implements and administers quality programs in accordance with applicable requirements, Standard Operating Procedures (SOPs), Good Laboratory Practices (GLPs), current Good Manufacturing Practices (cGMPs) and in compliance of ISO/IEC 17025:2005 to ensure integrity and consistency of quality systems and training. Essential Duties and Responsibilities:Quality Specialist may perform as acting Quality Manager as required.  Coordinates with multiple locations, units, and/or cost centersConducts internal auditsDetermines SOP applicabilityPeer reviews SOPs and other controlled documentsIdentifies and participates in process improvementsEvaluates responses to inspection reportsParticipates in external auditsImplements and monitors compliance with SOPsDefines, maintains, and implements new employee training SOPParticipates in development of training programsMonitors control chartsReviews methods for completeness and compliancePerforms other related duties as assigned
