6273 - LIMS Master Data System Specialist / SME Consultant

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

The LIMS Master Data System Specialist will be responsible for the creation and revision, as well as review and approval of LIMS master data within the LabVantage Laboratory Information Management System (LIMS) implemented at all sites for the GxP LIMS system. This position will be responsible for providing end-user support for all MFG, QC, QA, Supply Chain and analytical groups as well as compliance with global internal policies and procedures. The Sr. specialist is also responsible for LES worksheets design configuration and delivery. The Sr. specialist is responsible for supporting the EMUM program from LIMS perspective. The Sr. Specialist will drive the LIMS master data process from the very beginning to the end including change control management, master data verification, data migration etc. The Specialist will be supporting to increase LIMS data accessibility by writing Jasper Report and testing/installation of Jasper report onto LIMS system.

The responsibilities of this position may include, but are not limited to, the following:

• →Work with site leaders to identify, capture and update all master data for each site for GxP operations
• →Work with a project team to identify, capture and update all master data f
• →Leads QC, QA and MFG departments in the build and/or revision, review and approval of LIMS master data, including but not limited to products, sampling plan, specifications, methods, sample points, and LES templates in LIMS, per global and local LIMS procedures
• →First-line support for end-user LIMS LES templates and data entry issues, COA generation, EMUM data module etc.
• →Support in the development, implementation, enhancement of the overall process for requesting, creating/revising, and reviewing master data at site facilities\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
• →Work with the site LIMS Administrator and Business Owner to maintain site and global requirements of LIMS
• →Participate in the development and/or revision of Standard Operating Procedures
• →Support LIMS System/Process auditing to ensure data is current
• →Corporate with training for end users to use the system
• →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
• →Responsible to master data module maintenance and perform system master data related impact assessment and taking change actions
• →Build instruments and consumable including critical reagents master data in LIMS system

• Bachelor's degree in technology discipline or equivalent in technology or science discipline or equivalent. Combined degrees and/or experience in fields of biology, data analysis, Statistics and data science is preferred
• Typically requires 2- 4 years relevant experience in the Life Sciences, or the equivalent combination of education and experience
• Familiarity with cell and gene therapy methodologies such as Cell Viability, Flow cytometry and other cell functional assays
• Knowledge of LabVantage system master data and system usage functionality, requires at least 3 years of experience
• Knowledge of regulated systems – general level of understanding of systems validation
• Capable and comfortable multi-tasking between concurrent projects
• Experience of GxP laboratory and Manufacturing process, and non-GxP research laboratory analytical development and product processes development
• Must demonstrate ability to work in a team environment and willingness to assume additional or new responsibilities readily
• Must detail oriented pay close attention and notice minor details
• Effective communication skills, both verbal and written. Knowledge of regulated systems – general level of understanding of systems validation
• Skills of Master Data management in LIMS Systems, together with Data Analysis/Data Management
• Capable and comfortable multi-tasking between concurrent projects
• Onsite job requirement in Boston, MA