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This role is an Application Support Role for the Labware LIMS Application at the Sanofi Pasteur Swiftwater Site. The LIMS Business Administrator is essential to Quality Operations at the Swiftwater site for supporting the maintenance and improvement of the LIMS system. Maintenance support will include supporting Business and IS LIMS Administrators in report design and build, updating master data for new and existing products, updating master data for new and existing analysis, maintaining system documentation, and providing ad hoc support to other departments. The position is expected to provide leadership to support system evolution and continuous improvement, and to support laboratory informatics needs. Experience: 6 to 9 years.
The resource will act as a team resource to primarily support the Swiftwater effort:
Coordination of support activities for analysis and LabWare object enhancements. Assisting the team to define best approach as well as process for completion of the activities if necessary
Maintaining healthy relationships among different functional areas within IS regionally or globally as well as business customers
Submission and coordination of IS change management requests (ISCM), development of test scripts and associated IS documents as needed, and coordination of test execution for Sanofi Pasteur’s implementation of LabWare LIMS
The resource will need to provide input to or author documents according to the Sanofi Pasteur SW project methodology.
The resource will support QC Business teams with defining validation strategy and review / development of validation deliverables as per validation policy.
Other duties and assigned deliverables relevant to the LIMS or other lab quality system support, as deemed necessary by Sanofi Pasteur.
Support business and Global IS LIMS Administrator in the creation, validation and maintenance of reports, calculations, queries
Support the business and IS LIMS Administrator in the definition, approval and validation of new business Master Data requirements
Work with ITS and Business to transfer to a new Master Data Process
The candidate must meet the following criteria:
Understanding of GxP regulations and Computer Validation principles
Understanding of Document Management principles
Demonstrated technical writing and oral communication skills
Strong organization and interpersonal skills
Proficiency/experience in a regulated (e. g., GxP) environment
Proficiency/experience with Client Quality Center (testing tool, EDMS, MS office tools and/or TrackWise (change management tool)
Proficiency/experience with writing clear, concise, complete validation documents and test scripts with appropriate test coverage, for a given master data or application change
LabWare LIMS Experience
Overall proficiency/familiarity with key features of LWLIMS v6
Ability to quickly learn how Sanofi Pasteur North America uses LabWare LIMS (e.g., how master data is used to support business processes, how the application is customized, etc.)
Other Requested Skills
Working experience in the scientific laboratory in an FDA regulated environment strongly preferred
Balance of technical capability, process understanding, interpersonal skills, and pharmaceutical/business familiarity
Detail oriented -- ability to get things done "right the first time" in a regulated environment
Ability to work independently, efficiently and with a sense of urgency, within the established framework (thus maximizing output with sufficient quality, while also minimizing the need for unnecessary involvement from teammates or business contacts)
Ability to work collaboratively, so that pertinent issues are addressed as transparently and efficiently as possible
Ability to multi-task multiple priorities simultaneously (in order to keep multiple project assignments moving forward, even as priorities are changing)
Ability to quickly learn the steps in the Sanofi Pasteur IS change management process
Ability to work within the existing Sanofi Pasteur IS processes and procedures, using existing document templates, naming conventions, checklists, etc.
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