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Systems administrator • fort worth tx
Systems Administrator, Laboratory Systems
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POSITION OVERVIEW
The System Administrator, Laboratory Systems is a member of the corporate quality group responsible for
implementing and maintaining laboratory equipment at the Alora sites to ensure quality and regulatory
requirements are achieved (GAMP 5, cGMP, FDA 21 CFR Part 11). The System Administrator will also assist with
system and instrument validation / qualification. The sites include Fort Worth, TX and Marietta, GA.
DUTIES AND RESPONSIBILITIES
- Travel to Sites 50%
- Serve as an application level or system level administrator for laboratory equipment. Responsible for managing
the equipment lifecycle including delivery, integration, modification, and maintenance
regulatory requirements (GAMP 5, cGMP, FDA 21 CFR Part 11) and corporate policies by developing and
maintaining validation documentation including GxP Assessments, Change Controls, Validation Plans, Risk
Assessments, Requirements, Design / Functional Specifications, IQ / OQ / PQ Protocols, Trace Matrices, and other
documentation required for implementing and maintaining laboratory equipment and equipment software
process
risks, and acting proactively to resolve issues
equipment
objectives
EXPERIENCE AND QUALIFICATIONS
Annex 11 among others
the Pharmaceutical Industry
communication skills