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Labware LIMS Business Analyst
Ref No.: 18-09514
Location: Summit, New Jersey
Sunrise System Inc. is currently looking for Lab ware LIMS Business Analyst in Summit, NJ with one of our top client.
Job Title: Lab ware LIMS Business Analyst
Job Id: 18-09514
Location: Summit, NJ 07901
Position Type: Hourly contract Position (W2 only)
 
Key Accountabilities
  • Ensure site on-time implementation of LIMS activities through support of requirements definition, functional design, master data configuration and data migration, system validation, SOP revisions and development of end-user training.
  • Provide technical support of LIMS to Quality Control, Batch Release, Production, Stability and R&D operations
  • Support business and Global IS LIMS Administrator in the creation, validation and maintenance of reports, calculations, queries
  • Provide first level diagnostic of incidents and support business users, IS LIMS Administrator and Support Center in the management and timely resolution of technical
  • Responsible for the master data management process including the updating of specifications and supporting the approval process
  • Support the business and IS LIMS Administrator in the definition, approval and validation of new business requirements
  • Play a key role in system governance through participation in local and regional governance committees
  • Provide ad hoc support to other departments to ensure compliance with all regulatory standards
  • Support audits and inspections to provide data and information on request
  • Create and maintain processes to improve the regulatory review process
  • Ensure that the LIMS complies with all relevant regulatory standards Develop and manage LIMS improvement projects
  • Establish and lead required change controls
  • Improve process efficiency Support the training of new users
  • Support the business in the creation and updating of training materials as changes to system occur
  • Support the business in the delivery of training to end users and support management of associated system training records
  • Provide local advice and support to users
  • Write and revise processes and documentation 
Basic Qualifications
  • BS in Bachelor Degree in Computer Science, Life Sciences (Biology, Chemistry, or related discipline)
  • 3-5 years of experience in use and administration of a Lab Ware LIMS including LIMS Basic
  • Strong working knowledge of laboratory processes including cGMP's in a pharmaceutical environment
  • Experience in system testing, validation, and master data management
  • Familiar with 21CFR part 11 data integrity best practices in pharmaceutical environment
  • Excellent written and verbal communications skills and the ability to lead and participate in teams
  • Experience or familiarity of the Laboratory Environment 
Contact
Praful Prasanna
Email: Praful.P@sunrisesys.com | Direct: (732) 272 0326
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com