Atrium
Overview
Senior Business System Specialist role at Atrium. Base pay range: $50.00/hr - $60.00/hr. The Senior Business 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 the Vertex Cell and Gene Therapy sites (LC1, VCGT at VMC site) for the GxP LIMS system. This position provides end-user support for the EMUM program and ensures compliance with global Vertex internal policies and procedures. The Senior Specialist also manages stakeholders across functional leads and supports CGT @VMC site processes from a LIMS perspective. The Senior Specialist drives LIMS master data, including the EMUM process from start to finish, covering change control management, master data verification, and data migration. Key Responsibilities 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. Lead QA, QC and MFG departments in the build and/or revision, review, demo and approval of LIMS master data, including products, sampling plan, specifications, methods, sample points, and LES templates in LIMS, per global and local LIMS procedures. Provide first-line support for end-user LIMS LES templates and data entry issues, COA generation, EMUM data module, etc. Support the development and enhancement of the process for requesting, creating/revising, and reviewing master data for VCGT at VMC site facilities. Assist in developing and implementing a site process for scheduling and status tracking of all sites LIMS EMUM Master Data. Collaborate with the site LIMS Administrator and Business Owner to maintain site and global LIMS requirements. Participate in the development and/or revision of VCGT Standard Operating Procedures. Provide training to end users to use the system. Collect digital platform business requirements, user stories 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. Train Jr. specialists on system knowledge and assist with technical challenges in partnership with the technical lead. Maintain master data modules and perform system master data impact assessments and change actions. Build instruments and consumables master data, including critical reagents, in the LIMS system.
Qualifications
Bachelor's degree in technology discipline or equivalent in technology or science; combined degrees and/or experience in biology, data analysis, statistics, and data science are preferred. Typically 2-4 years of relevant experience in the Life Sciences, or an equivalent combination of education and experience. Knowledge of LabVantage master data and system usage functionality; at least 3 years of experience. Familiarity with Environment monitoring and Utility monitoring programs within a GxP pharmaceutical manufacturing environment. Knowledge of regulated systems with a general understanding of systems validation. Ability to multi-task between concurrent projects. Experience with GxP laboratory and manufacturing processes, and non-GxP research laboratory analytical development and product processes development. Demonstrated ability to work in a team environment and willingness to take on additional or new responsibilities. Effective verbal and written communication skills. Master data management skills in LabVantage LIMS systems, with data analysis/management capabilities.
Contract & Work Details
Contract Duration: 6 months with an opportunity for extension. Pay Range: $50/hr - $60/hr. Shift/Hours: Monday-Friday. No C2C or Third-Party Vendors.
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Senior Business System Specialist role at Atrium. Base pay range: $50.00/hr - $60.00/hr. The Senior Business 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 the Vertex Cell and Gene Therapy sites (LC1, VCGT at VMC site) for the GxP LIMS system. This position provides end-user support for the EMUM program and ensures compliance with global Vertex internal policies and procedures. The Senior Specialist also manages stakeholders across functional leads and supports CGT @VMC site processes from a LIMS perspective. The Senior Specialist drives LIMS master data, including the EMUM process from start to finish, covering change control management, master data verification, and data migration. Key Responsibilities 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. Lead QA, QC and MFG departments in the build and/or revision, review, demo and approval of LIMS master data, including products, sampling plan, specifications, methods, sample points, and LES templates in LIMS, per global and local LIMS procedures. Provide first-line support for end-user LIMS LES templates and data entry issues, COA generation, EMUM data module, etc. Support the development and enhancement of the process for requesting, creating/revising, and reviewing master data for VCGT at VMC site facilities. Assist in developing and implementing a site process for scheduling and status tracking of all sites LIMS EMUM Master Data. Collaborate with the site LIMS Administrator and Business Owner to maintain site and global LIMS requirements. Participate in the development and/or revision of VCGT Standard Operating Procedures. Provide training to end users to use the system. Collect digital platform business requirements, user stories 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. Train Jr. specialists on system knowledge and assist with technical challenges in partnership with the technical lead. Maintain master data modules and perform system master data impact assessments and change actions. Build instruments and consumables master data, including critical reagents, in the LIMS system.
Qualifications
Bachelor's degree in technology discipline or equivalent in technology or science; combined degrees and/or experience in biology, data analysis, statistics, and data science are preferred. Typically 2-4 years of relevant experience in the Life Sciences, or an equivalent combination of education and experience. Knowledge of LabVantage master data and system usage functionality; at least 3 years of experience. Familiarity with Environment monitoring and Utility monitoring programs within a GxP pharmaceutical manufacturing environment. Knowledge of regulated systems with a general understanding of systems validation. Ability to multi-task between concurrent projects. Experience with GxP laboratory and manufacturing processes, and non-GxP research laboratory analytical development and product processes development. Demonstrated ability to work in a team environment and willingness to take on additional or new responsibilities. Effective verbal and written communication skills. Master data management skills in LabVantage LIMS systems, with data analysis/management capabilities.
Contract & Work Details
Contract Duration: 6 months with an opportunity for extension. Pay Range: $50/hr - $60/hr. Shift/Hours: Monday-Friday. No C2C or Third-Party Vendors.
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