Job Description:
- Our client is seeking a Sr. Business Systems Specialist to support LIMS master data within the LabVantage system deployed at client sites. This candidate will be responsible for managing Master Data management for multiple sites including product, sampling lines, test methods, and lab execution data. Day to day activities will include significant cross functional collaboration with QC, QA, Supply Chain, MFG and analytical groups as well as the system SME to ensure business requirements and GxP compliance are met. This is a hands-on project and requires a substantial understanding of GMP regulations, the capability to define requirements, and provide presentations and ensure follow through activities have been completed. The ideal candidate should come from a hands-on analytical background and possess expert knowledge of Labvantage deployments in a GMP environment, strong communication skills, and demonstrated knowledge of master data requirements. Previous experience working with Domatics and Benchling ELN software would be beneficial for additional upcoming projects.
Skills:
- Work with site leaders to identify, capture and update all master data for GxP operations.
- Leads QC, QA and MFG departments in the build and/or revision, review and approval of master data, including but not limited to products, sampling plan, specifications, and methods in LIMS, per global and local LIMS procedures.
- Assist in the development and implementation of a site process for the scheduling and status tracking of all sites LIMS Master Data, including needs for Raw Material, Intermediate, Drug Substance and Finished Product, EM/UM and Stability testing.
- First-line support for end-user LIMS template and data entry issues.
- The business System Specialist will support electronic notebooks such as Benchling, Dotmatics, Non-GxP digital system implementation.
- Collect digital platform business requirements, user story and use cases, support user acceptance testing.
- Act as digital platform superuser and coordinate with business subject-matter experts from different levels for business needs.
- Responsible for training Jr. specialist with system knowledge and drive through technical difficulty in partnering with the technical lead.
- Act as digital platform superuser and coordinate with business subject-matter experts from different levels for business needs.
Education:
- Bachelors in Scientific discipline
On-Site: Senior Labvantage Specialist (234627)
