Systems Administrator, Laboratory Systems

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