Quality Managment Systems Business Analyst

Accenture San Ramon , CA 94582

Posted 3 weeks ago

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Do you want to work where scientific innovation meets leading-edge technology? Join Accenture Scientific Informatics Services and help our clients apply digital technologies to revolutionize scientific and laboratory processes.

Accenture Scientific Informatics Services combines the scientific and laboratory informatics expertise of LabAnswer with Accenture's strategic and business consulting capabilities, industry platforms, innovation approach and global scale to help transform how scientific and laboratory processes are conducted across a variety of industrieshelping make them faster, more efficient and more effective than ever before.

Leveraging digital technologies such as automation, artificial intelligence, Internet of Things, analytics and cloud, in combination with a fundamental redesign of the scientific user experience, Accenture Scientific Informatics Services helps organizations better capture, manage, integrate and analyze complex scientific data. This can improve the discovery and manufacturing of new products, improve quality, ensure compliance, reduce time to market and improve operational efficiency.

As a consultant with Accenture Scientific Informatics Services 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.

Under minimal supervision from a more senior business analyst or project manager:

  • Understand and Identify business processes and improvements for Quality Management Systems (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)

  • 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

  • Conduct meetings, document meeting notes and distribute meeting notes to invitees

  • Initiate 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 as-is 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

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Quality Managment Systems Business Analyst

Accenture