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LIMS Templator / LIMS Data Entry

West Greenwich, RI
“This company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and PuertRictbe vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations tstaff augmentation external workers whqualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship tthis company, its operations, or its staff.”

Top 3 Must Have Skill Sets:    
  • Familiar with system validation of computerized systems.
  • Familiar with SQL querying, excel logic, java or html is a plus.
  • Knowledge of lab operations, analytical lab techniques, commercialization, and cGMP.
  • Knowledge on Data Integrity Assessments (DIA) for computerized systems and execution of CFR 21 Part 11 for computerized systems.
  • Experience as a user (as a minimum) of LIMS System
Day Day Responsibilities:    
Hold a third level qualification in a Science related discipline.

Summary
The Laboratory Information Management System (LIMS) Upgrade project requires LIMS Templators / LIMS Data Entry resources support the data migration, LIMS templating and data entry efforts under the guidance and direction of the Business Workstream Lead and Project/Program Management.
This job specification outlines the general responsibilities associated with the role of LIMS Templator / LIMS Data Entry
Work within the LIMS Modernization Project Team tprovide laboratory business administration, implementation and technical support services for SM-LIMS, Biovia Smartlab (LMES) and Biovia CIMS (Inventory Management).
  • Review of Quality Documentation e.g. Sample Plans, FORMs and Environmental Monitoring sample plans, Methods, Specifications to:
  • Build, develop and maintain LIMS templates.
  • Evaluate new or revised LMES eProcedures in conjunction with SMEs.
  • Provide support for LMES eProcedure revisions
  • Provide support for CIMS updates
  • Work with the Documentation Writers to:
  • Provide support for SOP updates.
  • Assist with developing and deliver training documents.
  • Assist with UAT script writing
  • Be responsible for specific tasks within several workstreams associated the LIMS Modernization Upgrade project.
  • Ensure timely completion of each stage of the Project Tasks
  • Ensure flow of communication stakeholders.
Key Competencies:
  • Apply analytical thinking evaluate and interpret complex situations/problems using multiple sources of information.
  • Excellent verbal and written communication skills including technical writing, presentation and facilitation skills.
  • Work collaboratively with global business team
  • Ability work under minimal supervision.
  • Ability work in a fast paced environment with changing priorities.
  • Excellent Organizational and Time Management Skills.
  • Ability identify and manage competing priorities.
  • Anticipate and prevent potential problems.
  • Skills in the areas of teamwork, flexibility, coaching and motivating.
Knowledge and Experience:
  • Hold a third level qualification in a Science related discipline.
  • Minimum 4 years experience in a Biotechnology/ Pharmaceutical/ GMP Environment.
  • Familiar with (or can learn) new laboratory information systems and can self-teach technical topics.
  • Familiar with system validation of computerized systems.
  • Familiar with SQL querying, excel logic, java or html is a plus.
  • Knowledge of lab operations, analytical lab techniques, commercialization, and cGMP.
  • Knowledge on Data Integrity Assessments (DIA) for computerized systems and execution of CFR 21 Part 11 for computerized systems.
  • Experience as a user (as a minimum) of LIMS System

"This posting is for Contingent Worker, not an FTE"
 

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