Atrium
Overview
Join to apply for the
Business System Specialist
role at
Atrium . Base pay range
$40.00/hr - $50.00/hr Responsibilities
The 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 will be responsible for providing end-user support for EMUM program as well as compliance with global Vertex internal policies and procedures. The Specialist is also responsible for stakeholder management, across functional lead. The Specialist is responsible for supporting the CGT@VMC site processes from LIMS perspective. The Specialist will drive the LIMS EMUM master data process from the very beginning to the end including change control management, master data verification, data migration etc. Work with a project team to identify, capture and update all EMUM master data for the operations within VCGT at VMC site. Lead 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. Provide first-line support for end-user LIMS LES templates and data entry issues, COA generation, EMUM data module, etc. Support the development, implementation, and 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 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 for end users to use the system. Collect digital platform business requirements, user stories and use cases, and support user acceptance testing as needed. Act as digital platform superuser and coordinate with business subject-matter experts from different levels for business needs. Maintain master data modules and perform system master data related impact assessments and change actions. Build instruments and consumables including critical reagents master data in LIMS system. Qualifications
Bachelor's degree in technology, science or related discipline; combined degrees and/or experience in biology, data analysis, or bioinformatics are preferred. Typically requires 1-3 years of relevant experience in Life Sciences or equivalent. Knowledge of LabVantage master data and system usage functionality, with at least 1 year of experience. Familiarity with Environment monitoring and Utility monitoring programs within a GxP pharmaceutical manufacturing environment. Experience of GxP laboratory and manufacturing processes. Ability to work in a team environment and willingness to assume additional responsibilities. Effective verbal and written communication skills; general understanding of systems validation. Skills in Master Data management in LabVantage LIMS systems, with data analysis/management capabilities. Ability to multi-task across concurrent projects. Contract Duration:
6 months with an opportunity for extension Additional
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals. The individual selected for this role will be offered the role as an employee of a third-party agency partner; compensation and benefits will be provided by the third-party agency partner. The pay range provided is an estimate at the time of posting and may be adjusted based on factors including skills, competencies, experience, and location. Overtime eligibility may apply in accordance with federal and state requirements. By applying, you agree to Atrium Terms and Conditions and authorize Atrium to share your application materials with Vertex. For privacy details, see Vertex Careers Privacy Notice. #J-18808-Ljbffr
Join to apply for the
Business System Specialist
role at
Atrium . Base pay range
$40.00/hr - $50.00/hr Responsibilities
The 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 will be responsible for providing end-user support for EMUM program as well as compliance with global Vertex internal policies and procedures. The Specialist is also responsible for stakeholder management, across functional lead. The Specialist is responsible for supporting the CGT@VMC site processes from LIMS perspective. The Specialist will drive the LIMS EMUM master data process from the very beginning to the end including change control management, master data verification, data migration etc. Work with a project team to identify, capture and update all EMUM master data for the operations within VCGT at VMC site. Lead 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. Provide first-line support for end-user LIMS LES templates and data entry issues, COA generation, EMUM data module, etc. Support the development, implementation, and 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 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 for end users to use the system. Collect digital platform business requirements, user stories and use cases, and support user acceptance testing as needed. Act as digital platform superuser and coordinate with business subject-matter experts from different levels for business needs. Maintain master data modules and perform system master data related impact assessments and change actions. Build instruments and consumables including critical reagents master data in LIMS system. Qualifications
Bachelor's degree in technology, science or related discipline; combined degrees and/or experience in biology, data analysis, or bioinformatics are preferred. Typically requires 1-3 years of relevant experience in Life Sciences or equivalent. Knowledge of LabVantage master data and system usage functionality, with at least 1 year of experience. Familiarity with Environment monitoring and Utility monitoring programs within a GxP pharmaceutical manufacturing environment. Experience of GxP laboratory and manufacturing processes. Ability to work in a team environment and willingness to assume additional responsibilities. Effective verbal and written communication skills; general understanding of systems validation. Skills in Master Data management in LabVantage LIMS systems, with data analysis/management capabilities. Ability to multi-task across concurrent projects. Contract Duration:
6 months with an opportunity for extension Additional
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals. The individual selected for this role will be offered the role as an employee of a third-party agency partner; compensation and benefits will be provided by the third-party agency partner. The pay range provided is an estimate at the time of posting and may be adjusted based on factors including skills, competencies, experience, and location. Overtime eligibility may apply in accordance with federal and state requirements. By applying, you agree to Atrium Terms and Conditions and authorize Atrium to share your application materials with Vertex. For privacy details, see Vertex Careers Privacy Notice. #J-18808-Ljbffr