Business System Specialist​/Senior Data Analyst

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• 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 Business System Specialist will be responsible for the creation and revision, as well as review and approval of LIMS master data within the Lab Vantage Laboratory Information Management System (LIMS) implemented at the Vertex Cell and Gene Therapy sites (LC1, Cambridge and VCGT at VMC site) 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 Vertex internal policies and procedures.

The specialist is also responsible for LES worksheets design configuration and delivery. The specialist is responsible for supporting the EMUM program from LIMS perspective. The 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.

Business System Specialist Responsibilities:

• Work with site leaders to identify, capture and update all master data for each site within VCGT (Cambridge, LC1 and VMC site) for GxP operations
• Work with a project team to identify, capture and update all master data for PD operations within VCGT (Cambridge, LC1 and VCGT at VMC site)
• 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 the VCGT Cambridge, LC1 and 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 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
• Assist 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 consumables including critical reagents master data in LIMS system

Requirements:

• Bachelor's degree in technology discipline or equivalent in technology or…