Business Systems Senior Specialist (Contract)

The Business System 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 (LC1, VCGT at VMC site) for the GxP LIMS system. This position will be responsible for providing end-user support for EMUM program as well as compliance with global Vertex internal policies and procedures. The Sr. specialist is also responsible for stakeholder management, across functional lead. The Sr. specialist is responsible for supporting the CGT @VMC site processes from LIMS perspective. The Sr. Specialist will drive the LIMS master data including EMUM process from the very beginning to the end including change control management, master data verification, data migration etc.

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 @VMC site for GxP operations.
• Work with a project team to identify, capture and update all EMUM master data for the operations within VCGT at VMC site.
• Leads QC, QA and MFG departments in the build and/or revision, review, demo 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 for VCGT at VMC site facilities.
• Assist in the development and implementation of a site process for the scheduling and status tracking of all sites LIMS EMUM Master Data.
• 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.
• Corporate with training for end users to use the system.
• Collect digital platform business requirements, user story and use cases, support user acceptance testing as needed.
• 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.  

Minimum qualifications:

• 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.
• Knowledge of LabVantage master data and system usage functionality, requires at least 3 years’ experience.
• Familiarity with Environment monitoring and Utility monitoring program within a GxP pharmaceutical manufacturing environment.
• 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 LabVantage LIMS Systems, together with Data Analysis/Data Management.
• Capable and comfortable multi-tasking between concurrent projects.

Contract Duration: 6 month with an opportunity for extension. 

$50/hr.-$60/hr.

Monday-Friday

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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