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Labware LIMS Validation
Ref No.: 18-09513
Location: Summit, New Jersey
Sunrise System Inc. is currently looking for Lab ware LIMS Validation in Summit, NJ with one of our top client.
 
Job Title: Lab ware LIMS Validation
Job Id: 18-09513
Location: Summit, NJ 07901
Position Type: Hourly contract Position (W2 only)
 
Purpose and Scope of Position
  • The LIMS Specialist is responsible for the management of the LIMS (Laboratory Information Management System)/ eLN (electronic lab notebook) in support of the chemistry and microbiology CAR-T QC laboratories.
  • This includes, but is not limited to, maintaining, updating and troubleshooting all LIMS/eLN related issues and assisting with system updates and/or enhancements. 
Required Competencies: Knowledge, Skills, and Abilities
  • Advanced knowledge of Lab Ware or related LIMS/eLN
  • Advanced knowledge of LIMS basic coding and code reviews
  • Advanced knowledge of validation and/or maintenance of laboratory information systems
  • Knowledge of cGMP Regulations and how they apply to QC laboratories
  • Knowledge of analytical/microbiological test methods and environmental monitoring programs
  • Knowledge of controlled barcode label printing
  • Knowledge of Crystal Report design
  • Ability to perform ADHOC inquires
  • Strong written and verbal communication skills
  • Detail-oriented with expertise in problem solving; solid decision-making abilities
  • Strong interpersonal skills
  • Strong ability to work independently and compliantly Results driven 
Duties and Responsibilities
  • System Management
  • Execute, Create or revise computer system validation documents (i.e. URS, OQ, PQ, etc.) as applicable
  • Manage all buildouts and changes in LIMS/eLN for the QC lab
  • Support IT in the Administration of the LIMS/eLN program
  • Manage change controls for LIMS/eLN changes
  • Create and maintain user accounts
  • Troubleshoot issues and solve problems with minimum guidance
  • Serve as SME for QC LIMS
  • Provide routine support for end users
  • Assist with errors and troubleshooting
  • Provide end user training and on-the-job training (OJT) for laboratory and production employees
  • Maintain master data objects
  • Participate in internal audit of the system and system documentation
  • Assist management with investigations and deviations
  • Create and maintain all LIMS related SOPs
  • Support site projects and goals where applicable to streamline testing
  • Assist management with the development, implementation and deployment of training
  • Performs other tasks as assigned. 
Education and Experience
  • Bachelor's Degree required, preferable in Science
  • Advanced Degree preferred
  • 5-8 years of relevant work experience, preferable in a regulated environment.
  • 3-5 years of Lab Ware or related LIMS experience
  • Previous experience with validation and/or maintenance of laboratory information systems
  • Previous experience with MODA-EM a plus
  • An equivalent combination of education and experience may substitute 
Contact
Vishal Tejaswi
Desk:732-272-0312 | Email: vishal.t@sunrisesys.com
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com