Senior Quality Specialist

Essential Duties and Responsibilities Leads andproject managesQMSactivitiesincluding document control, change control, non-conformancereportingand supplier qualification/requalification Serves as team lead CSV specialist Responsible for data reduction,metricsand managerial reports delivery Supervise andassistin management ofQMSNon-Conformance reporting and their relatedinvestigation, root cause analysis, proposed corrective and/orpreventive measures,and due diligence thereto TrainsQMS users on workflow and associated tasks for modules within the QMS LeadseQMSconfiguration and improvement specialist Assesses, creates, and presentsQMSLean and Process Efficiency opportunities and projects Assistsmanagement in assuring organizational readiness for regulatory inspections by scheduling, coordinating,conductingand documentingQMS modulegap analyses Provide industry leadingQMScompliance guidance and quality assurance consultation to internal and external stakeholders Clear and concise communication ofQMSreporting for regulatory and quality consulting advisements Schedules and conducts monthly quality review meetings asrequired Prepare training materials and conduct training for QMStopics Collaborates with Human Resourcesregardingtraining program requirements affected by the QMS Serves as Quality subject matter expert for configurable systems validation projects Conducts research, and compiles andtypesstatistical reports Performs other tasks as defined by the QualityAssuranceLeadership Education and Experience 4 -year degree preferred with5-7years of Quality Assurance Experience; ora 2-year degree with8-10yearsrelated experience and/or training; or equivalent combination of education and experience. Veeva Belt certification preferred. Skills and Ability Mustpossessstrong organizational and interpersonal skills. Experience with QMS platforms such as Veeva is highly preferred. Proventrack recordof leading QMS implementations or enhancements is a strong asset. Supervisory Responsibilities: None Physical Demands: While performing the duties of this job, the occupant is regularly required to: Prolonged periods of sitting at a desk and working on a computer. Prolonged use of computer and headphones for conference calls. Communicate effectively via phone, video, and email. Use hands and fingers to operate a computer and other office equipment. Travel Requirements: Minimal #J-18808-Ljbffr