What are the responsibilities and job description for the Labware LIMS Specialist position at Eclaro?
Job Description: Job Summary
Client is seeking a LIMS Specialist at Cell Therapy Facility (CTF) in Summit, NJ. The LIMS Specialist is responsible for the management of LIMS (Laboratory Information Management System) and eLN (electronic laboratory notebook) applications with minimal supervision in support of QC laboratories, during the clinical and commercial manufacturing activities. This includes, but is not limited to, maintaining, updating, and working with Cell Therapy central LIMS supporting functions to troubleshoot all LIMS related issues and assisting with system updates and enhancements, as a subject matter expert. This position will also be the LIMS technical representative to interface with multiple groups, in integration between LIMS, Manufacturing Electronic System and SAP systems.
The LIMS Specialist role is stationed in Summit, NJ and reports to the LIMS Manager QC Systems.
Job Responsibilities:
Create and execute computer system validation documents (i.e. UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers
Create and maintain LIMS related SOPs to direct QC on using the system
Provide operations support to end users including weekends or late hours as per site need.
provide guidance in the implementation of new LIMS functionality
Support IT in the Administration of the LIMS/eLN program and manage change controls for LIMS/eLN changes
Function as system superuser where applicable and track/maintain user metrics
Maintain master data objects and guide QC personnel on creating masterdata sets
Troubleshoot issues, solve problems and assist with investigations and deviations with minimum guidance
Support Business buildouts, interface with multiple groups in integration between LIMS, Manufacturing Electronic System and SAP systems, manage changes in LIMS/eLN for QC labs and support harmonization on LIMS business processes within Cell Therapy where possible
Participate in inspection of the system and system documentation
Assist with the development, implementation and deployment of training
Provide end user training and on-the-job training (OJT) for laboratory and production employees where required
Qualifications and Education Requirements
Advanced knowledge of LabWare or related LIMS/eLN software, Crystal Report design and Ad Hoc inquiries
Advanced knowledge of validation and/or maintenance of laboratory information systems and GMP regulations
Knowledge of analytical and microbiological test methods and environmental monitoring programs
Knowledge of controlled barcode label printing
Detail-oriented with expertise in problem solving and solid decision-making abilities
Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
Ability to work with management locally and globally.
Strong written and verbal communications skills and interpersonal skills; Advanced ability to communicate effectively with peers, department management and cross-functional peers
Bachelors degree required, preferably in computer science or relevant science
3-5 years of relevant work experience, preferably in a regulated environment, with 3 years of LabWare LIMS experience or Ba
Previous experience with validation and/or maintenance of laboratory information systems
An equivalent combination of education and experience may substitute.
Additional Job Requirements:
None
Contract length: 6 months
Job Types: Full-time, Contract
Salary: $56.00 - $60.00 per hour
Schedule:
- 10 hour shift
