LIMS Systems Administrator
Job Summary
This position is responsible for installing, configuring, and maintaining a laboratory information management system (LIMS) in a GMP facility, as well as integrating LIMS with other systems. The LIMS Systems Administrator will also be the primary administrator within the quality management system and be required to configure, maintain and upgrade this system. The position will also perform end-user training and support functions for related administered systems. Will establish and document standards and procedures related to GxP systems.
Essential Functions
LIMS systems installation, administration, and systems integration
Quality management system administration (Trackwise)
Develop Standard Operating Procedures for use in GxP Facility
Provide Levels 1, 2 and 3 help desk support
and end-user training
Other duties as assigned
Scope Measures:
Makes recommendations on IT related budget items and assists in the writing of policies and procedures that affect the organization. Will work closely with the business users of the systems being administered to ensure the business goals are being met.
Knowledge/Skills/Abilities Required:
BS/BA in MIS, CIS or related field or equivalent experience required
5-7 years of IT experience with at least 3 years in a GxP environment required
LIMS administration experience required
Strong knowledge of cGMP/ICH/FDA regulations with 21 CFR Part 11 and GAMP knowledge a plus
Experience with change control and software validation preferred
Microsoft Active Directory experience a plus
SQL DBA experience is a plus
Cisco experience is a plus
Must be able to lift up to 50lbs
Must be available to work after hours and weekends when necessary. Must be available for after-hours support
Please refer to job code 4331-JM when responding to this ad.
Location: Exton, PA
Compensation: open
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