Title: LIMS Templator / LIMS Data Entry
Location: Dun Laoghaire
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.
* 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:
o Build, develop and maintain LIMS templates.
o Evaluate new or revised LMES eProcedures in conjunction with SMEs.
o Provide support for LMES eProcedure revisions
o Provide support for CIMS updates
* Work with the Documentation Writers to:
o Provide support for SOP updates.
o Assist with developing and deliver training documents.
o 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.
* 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.
Qualifications 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
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.