The LIMS / LES Administrator position is essential to supporting the maintenance and improvement of these electronic systems. The Laboratory Information Management Systems (LIMS) / Laboratory Electronic System (LES) Administrator oversees, executes and manages the administration, computing, reporting, training and validation of the Labware LIMS and Biovia LES applications. This position provides leadership to support system evolution and continuous improvement, and to support laboratory informatics needs across multiple departments.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
•Support the development, configuration, solutions evaluation, validation and deployment of LIMS System (Labware). Roll out the new version of the LIMS to laboratory and quality personnel.
•Support the continued development, configuration, validation and deployment of additional LES protocols as they become available.
•Serve as site technical expert and resource for all LIMS and LES-related inquiries and issues.
•Serve as point of contact for Labware LIMS and Biovia LES manufacturers.
•Support the maintenance, design and build of Labware LIMS software according to business requirements and needs.
•Support the maintenance, design and build of new and existing LES protocols according to business requirements and needs.
•Update or create master data for existing and new products including specifications, components, test plans and certificates of analysis.
•Set up and maintain user groups and individual LIMS and LES accounts.
•Utilize site change control system documentation.
•Maintain accurate and complete system documentation.
•Support audits and inspections as the SME for questions or discussions related to LIMS and LES are requested.
•Write and revise procedures, processes and documentation.
•Support the business in the creation and updating of training materials as changes to these systems occur.
•Work with site IT on the development and maintenance of interfaces with other business systems.
•Support the delivery of training to end users and maintenance of training records.
•Comply with all site policies and practices.
•Provide local advice and support to users.
•Write and revise processes and documentation as related to LIMS and LES.
•Support all documentation processes as required.
•Follow all site and company standard operating procedures as they relate to compliance to cGMP guidelines and practices.
•Perform all other related duties as assigned.Qualifications
•Education: Bachelor’s degree (B.A./B.S.) or equivalent in biological sciences or related discipline required.
•Experience: A combined minimum of 5 years related experience in the pharmaceutical industry in a role involving LIMS or in a laboratory or research environment is required.
•Strong knowledge and experience in the use and administration of Labware LIMS is required.
•Experience in system testing, validation and master data management recommended.
•Familiar with 21CFR part 11 requirements recommended.
•Excellent written and verbal communication skills and the ability to lead and participate in teams.
•Other: Ability to multi-task, excellent written and verbal communication skills, organizational skills, and attention to detail required. Possess analytical thinking and problem solving skills. Ability to prioritize and re-evaluate priorities as situations change. Working knowledge of computer software (ERP systems, MS Office, MS Project, Excel and database experience preferred). Knowledge of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations.
•Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
•Must regularly communicate with employees/clients and must be able to exchange accurate information verbally and in writing.
•Must occasionally move about inside the office to access file cabinets, office machinery, etc. Must be able to move between the office and research areas and visit other buildings.
•General office working conditions.
•The noise level in the work environment is usually quiet.
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet