Accenture Quality Business Process Dev Senior Analyst in New York, New York
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As an Accenture Scientific Informatics Services (ASIS) consultant you will be exposed to the technologies and processes that many leading US companies and government agencies utilize. We offer a generous compensation package consisting of salary, bonuses and benefits.
Understand and Identify business processes and improvements for QMS domain in a GMP environment. In order of importance, prior QMS related experience should include CAPA, Change Control, Investigation Management, Document Management, and Training Identify opportunities for improvement and efficiencies gained by successfully adopting new QMS solutions i.e. Veeva, Master Control, Trackwise, ComplianceWire, SumTotal.
Under minimal supervision from a more senior business analyst or project manager
With business stakeholders, implement business process improvements
Create use cases
Create high quality user and functional requirements
Analyze requirements to determine priority and business value
Facilitate meetings, document meeting notes and distribute meeting notes to invitees
Facilitate interviews, site visits and workshop sessions with business users one-to-one and in groups.
Create required regulatory and SDLC documentation
Collect information regarding and monitor progress of business analysis activities
Create ASIS and to-be process maps and narratives
Create requirements traceability matrices
Provide estimates for workstream activities, including dependencies, to the Project Manager
Identify, manage and resolve risks and issues related to the workstream
Provide Project Manager with status updates, activity progress and schedule updates Maintain excellent client relationships
Review and estimate change requests
Create and maintain SDLC documentation
Contribute to all areas of system implementation including but not limited to vendor interaction, system compatibility, change control, qualification, deployment, and training Work with project teams to ensure compliance with regulatory requirements such as FDA, CAPA, CLIA, GxP,HL7 as well as internal policies and processes
Create and deliver training materials to end users
Collect and monitor progress on project activities from resources
Determine and document overall workstream approach plan and estimate activities within the workstream
Provide leadership for all resources within a specific workstream including client, vendor, consultants and associates
Perform stakeholder identification and analysis Determine if defects are valid and disposition them
1 Year of experience in QMS projects with understanding of a single system type within the QMS domain.
1 Year of experience working in Life Sciences /FDA regulated environments
1 Year of consulting experience
Expert understanding of a single industry
Good understanding of three or more system types and their interrelationships within the QMS domain
Certified Business Analysis Professional CBAP certification
Excellent written and verbal communications skills
Excellent organizational skills
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Accenture.
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