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LIMS Business Analyst
Job ID:26039
Durham, North Carolina

RESOLVIT

Bringing Solutions That Make Business Better

We are seeking a LIMS Business Analyst to be part of a creative, forward-thinking team. Our success at deploying skilled, highly knowledgeable experts has landed us on the Inc. 5000 list of America’s fastest-growing companies four times – and we’re just getting started.

As the LIMS Business Analyst, you will act as a Global Business Representative on LabVantage LIMs system/software projects, working with the local site representatives to ensure harmonization across all sites. You will develop practical and innovative ways to identify and meet short and long term goals. You will also acquire and foster a strong understanding of the global QC environment, including interdependent systems, in order to facilitate the implementation of application interfaces, equipment interfaces, and alignment of master data. In addition, you will:

  • Drive and coordinate the change control process for the respective equipment and interfaces, in alignment with both global and regional strategy and priorities of responsibility, working closely with the relevant leaders and the IS business planners
  • Challenge current processes, identify improvements, and drive the effort to implement while maintaining compliance
  • Be directly responsible for requirements gathering (URS definition), validation test case authoring, and execution efforts in accordance with defined software life cycle processes
  • Assess new/changing regulatory and business requirements to ensure global policies, processes, and process governance meet regulatory and business expectations
  • Establish trusted relationship with relevant areas of senior management at global and local levels
  • Work with the project teams to ensure the validated state is maintained by executing periodic assessments
  • Represent system documentation during internal and external audits (FDA, ISO, corporate, ANVISA)
  • Serve as technical lead for tools, techniques, and management systems for Quality Assurance, Compliance, and continuous quality improvement
  • Participate in the implementation of Global Quality Objectives (process standardization, lessons learned) identifying and driving continuous improvement in relevant processes and quality attributes
  • Interface with external organizations and supporting functions and serve as a global project team member
  • Participate in the development and execution of training on quality processes
  • Coordinate, direct, and coach the activities of project team members
  • Develop, review, and execute qualification and validation protocols

What You’ll Need to be Successful:

  • 5 to 8 years of relevant experience
  • Bachelor’s degree with below years of industry experience or equivalent experience according to levels; Master’s degree preferred
  • Working knowledge of 21 CFR Part 11
  • Expertise in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE)
  • Good communication skills
  • Ability to work independently and in a team environment
  • Advanced competency in the selection and use of Quality Engineering Tools and Techniques

We currently have more than 100 open career opportunities across the country, so be sure to mention the appropriate Job Code with any correspondence!

About Resolvit:

Resolvit is an international technology consulting firm with industry-leading customers in the financial services, high tech, manufacturing, retail, life sciences, and government sectors. Through its partnerships, Resolvit delivers highly impactful, innovative solutions across five core areas: Infrastructure Modernization, Application Development Services, Enterprise Data Management & Analytics, Knowledge & Content Management, and Strategic Staffing.