Us Citizen
Green Card
EAD (OPT/CPT/GC/H4)
Corp-Corp
Consulting/Contract
UG :- - Not Required
PG :- - Not Required
No of position :- ( 1 )
Post :- 11th Mar 2021
Job Description :
Responsible for LabWare Laboratory Information Management System (LIMS) design, implementation, management and support focused on environmental monitoring and product sampling. Must have experience within in a cGMP environment.
The LIMS system administrator will support the existing deployments of the LabWare LIMS system across 3 sites within Viral Vector Services (VVS). The existing deployments are focused on environmental monitoring (3 sites) and product sampling (2 sites).
Responsibilities:
* Design and implement approved enhancements, stored queries, or crystal reports to support business operations already deployed on LabWare LIMS.
* Train and setup new end users on the use of the LIMS system
* Diagnose and troubleshoot issues raised by end users.
* Assist with investigations for deviations.
* Support regulatory audits or inspections as a system administrator / system expert.
* Assist in the development or maintenance of required documentation in a cGMP environment.
Requirements:
* BA/BS required in Life Sciences, IT related discipline or equivalent experience with 8+ years of appropriate work experience preferred.
* Knowledge of IT Control methodologies, including GAMP5 and solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity.
* Knowledge of the computerized system lifecycle activities, CSV and IT controls in a regulated environment.
* Admin Certification in LabWare 7 is a plus.
* Strong communication skills, both verbal and written.
* Ability to work both independently and with teams at various levels in the organization.
* Ability to work in a very dynamic environment with a clear sense of urgency.
* Excellent organizational skills and attention to detail and accuracy.
* Experience supporting health authority inspections a plus