LabVantage LIMS Master Data Specialist jobs in United States
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The Planet Group · 5 days ago

LabVantage LIMS Master Data Specialist

The Planet Group is a global biotech organization seeking a LabVantage LIMS Master Data Specialist for a 6-month onsite contract in Boston. The role involves the creation, revision, review, and approval of LabVantage Master Data for Cell and Gene therapy sites, ensuring compliance within a GxP LIMS system.

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H1B Sponsor Likelynote
Hiring Manager
Kelly Andrews
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Responsibilities

Creating, revising, reviewing and approving LabVantage Master Data for organizational Cell and Gene Therapy sites and within a GxP LIMS
Ability to drive the master data process from beginning to end, to include change control management, master data verification, and data migration
Assist to increase LabVantage data accessibility by writing, testing, and installing Jasper reports into LIMS
Providing user support to include manufacturing, quality control/assurance, supply chain and analytical groups, while adhering to compliance and global organizational policies and procedures
Performing LES worksheet design, configuration, and delivery
Working with site leads to identify, capture, and update master data for each site
Leading QA, QC and Manufacturing in the build/revision, review, and approval of LIMS master data to include products, sampling plans, specifications, methods, sample points, and LES templates in LIMS, Ensuring work conducted is within global and local required procedures
Serve as first-line of support for end users LIMS LES templates and data entry issues, to include COA generation, EMUM data modules and more
Supporting the overall process for requesting, creating, revising, and reviewing master data regarding system development, implementations, and enhancements
Assisting in the development/implementation of site processes regarding scheduling and status tracking of LIMS Master Data at various sites to include areas of Raw Material, Intermediate, Drug Substance, Finished Products, EM/UM, and Stability testing
Working with LIMS Administrator and Business Owners in the maintenance of site and global LIMS requirements
Participating in the development and revision of organizational Standard Operating Procedures
Supporting LIMS and Process auditing, while ensuring data is current
Performing corporate training for end users on LabVantage system utilization
Collecting LIMS business requirements to include user stories and use cases, while supporting user acceptance testing
Liaising as platform SME to coordinate with business SMEs regarding various business needs
Partnering with technical lead to train junior specialist on system utilization and functionality
Performing master data module maintenance and system data impact assessments while implementing change actions as required
Building instrumentation and consumables to include critical reagents and master data, in LIMS

Qualification

LabVantage LIMSGxP Lab/ManufacturingCell/Gene TherapySystems ValidationJasper ReportingLES Worksheet DesignLife Sciences DegreeSoft Skills

Required

Bachelor's degree within life sciences or similar areas
Reside locally to be onsite 5 days a week; within a commutable distance
3+ years' experience in LabVantage LIMS master data and systems
Familiarity with both cell and gene therapy methodologies like Flow Cytometry, Cell Viability and other Cell Functional Assays
A general understanding of systems validation
Expertise within GxP Lab/Manufacturing processes, as well as non-GxP research laboratory analytical development and product process development
Knowledge and ability to write, test, and install Jasper reporting into LabVantage system
Ability to perform LabVantage LES worksheet design configuration and delivery

Benefits

Opportunity offers a 6-month contract with likely extensions.

Company

The Planet Group

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The Planet Group is a global advisory and staffing firm operating at the intersection of talent and transformation.

H1B Sponsorship

The Planet Group 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
2021 (1)

Funding

Current Stage
Late Stage
Total Funding
unknown
Key Investors
MidOcean Partners
2021-05-27Acquired
2018-01-22Private Equity

Leadership Team

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Tim Simmerly
Chief Executive Officer
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Company data provided by crunchbase