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LIMS Templator/LIMS Data Entry - REMOTE (JP9304)

West Greenwich, RI · Biotech/Pharmaceutical
Job Title:  LIMS Templator/LIMS Data Entry - REMOTE (JP9304)
Location: West Greenwich, RI. 02817
Employment Type:  Contract
Business Unit:  Quality Operations
Duration: 2+ years (with likely extensions)
Notes: 100% REMOTE
Posting Date:  10/13/2021

3 Key Consulting is hiring a LIMS Templator/LIMS Data Entry for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The Laboratory Information Management System (LIMS) Upgrade project requires LIMS Templators / LIMS Data Entry resources to 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 to provide 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 to the LIMS Modernization Upgrade project.
  • Ensure timely completion of each stage of the Project Tasks
  • Ensure flow of communication to stakeholders.

Why is the Position Open?
Supplement additional workload on team.

Top 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 to Day Responsibilities:
Hold a third level qualification in a Science related discipline.

Basic Qualifications:
Key Competencies:
  • Apply analytical thinking to 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 to work under minimal supervision.
  • Ability to work in a fast paced environment with changing priorities.
  • Excellent Organizational and Time Management Skills.
  • Ability to 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

Employee Value Proposition:
To work for a dynamic team

Interview process:
Phone screening followed by in-person interview.



We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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