Verista · 6 hours ago
6036 - Senior Digital System Specialist / Business Analyst
Verista is a company that teams up with the world’s most recognizable brands in the life science industry to solve their business needs. The Senior Digital System Specialist will be responsible for the creation, revision, review, and approval of LIMS master data within the LabVantage LIMS system, providing end-user support and ensuring compliance with internal policies.
ComplianceHealth CareLife ScienceManufacturingPharmaceutical
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
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
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
Qualification
Required
Bachelor's degree in technology discipline or equivalent in technology or science discipline or equivalent
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, requires at least 3 years of experience
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
Capable and comfortable multi-tasking between concurrent projects
Onsite job requirement in Boston, MA
Preferred
Combined degrees and/or experience in fields of biology, data analysis, Statistics and data science is preferred
Benefits
High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
Company
Verista
Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.
H1B Sponsorship
Verista has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (13)
2022 (6)
2021 (1)
Funding
Current Stage
Late StageRecent News
2023-12-22
2023-12-22
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