The Clinical Business Systems Specialist Senior 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 the Vertex Cell and Gene Therapy sites (Cambridge/LC1 and Providence) for the GxP LIMS system. This position will be responsible for providing end-user support for all QC, QA, Supply Chain, MFG and analytical groups as well as compliance to global Vertex internal policies and procedures. The Business Analysts will be supporting non-GxP digital system implementation activities and corporate with AD, PD and R&D groups for multiple programs such as T1D and DMD. Additionally, the Business Analyst may be tasked to participate in a global process for general or Vertex Global applicable master data creation, revision, and review.
Key Responsibilities:
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 within VCGT (Cambridge, Providence and LC1) for GxP operations.
- Work with a project team to identify, capture and update all master data for PD operations within VCGT (Cambridge, Providence and LC1).
- 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.
- First-line support for end-user LIMS template and data entry issues.
- Support in the development, implementation, enhancement of the overall process for requesting, creating/revising, and reviewing master data at the VCGT Cambridge, Providence and LC1 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 VCGT Standard Operating Procedures.
- Support LIMS System/Process auditing to ensure data is current.
- The business analyst will support electronic notebooks such as Benchling, Dotmatics, Non-GxP digital system implementation to support CGT programs.
- 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.
Minimum Qualifications:
- Advanced degree 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, require at least 1 year experience.
- Knowledge of Benchling system - general function and system navigation.
- Knowledge of Dotmatics system – general function and system navigation.
- Knowledge of Instrument Data Capture system.
- 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.
- Skills of Master Data management in LIMS Systems, together with Data Analysis/Data Management.
Pay Range: $55-65/hr
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