QMS Business Analyst

Accenture – Memphis, TN

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 Accentures 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
    Basic Qualifications:

  • Expert understanding of a single industry
  • Expert understanding of a single system type within the QMS domain
  • 3+ Years of experience in QMS projects
  • 3+ Years of experience working in regulated environments

  • Desired Qualifications:

  • 3+ Years of consulting experience
  • Good understanding of three or more system types and their interrelationships within the QMS domain
  • Certified Business Analysis Professional (CBAP) certification
  • 4 Year degree in an applicable field
  • 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 (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).

    Accenture is an EEO and Affirmative Action Employer of Females / Minorities / Veterans / Individuals with Disabilities.

    Accenture is committed to providing veteran employment opportunities to our service men and women.

    Equal Employment Opportunity - All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

    Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.

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