Computer Validation Analyst - LIMS/PKS

Job type:
on-site
Start:
01-04-2012
Duration:
n.a
From:
Experis: Formerly Manpower Professional
Place:
California
Date:
12/21/2011
Country:
flag_no USA
project ID:
285036

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Computer Validation Analyst - LIMS/PKS

Experis IT(A ManpowerGroup Company) is seeking a Computer Validation Analyst - LIMS/PKS for a project in North Los Angeles with a Biotechnology/Pharmaceuticals Company.

Computer Validation Analyst - LIMS/PKS

  • Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems.
  • Responsibilities include participation in authoring and review of validation documents, preparation of test protocols, actual test execution, analysis of test results, tracing to requirements, and preparation of summaries and supporting documents for validation activities.
  • Supporting tasks also include managing changes (ie, system changes) using an electronic change management system and following associated business processes, and managing documents using an electronic document management system.
  • Will be asked to perform coordination tasks and follow-up tasks in support of a Validation Lead/Project Lead on validation projects.
  • Attention to detail and quality and able to learn quickly and execute tasks in an efficient and effective manner will be key.
  • Able to communicate effectively (verbally and written) is also key.
  • Good writing skills will be key.
  • 1 year+ experience with regulated Laboratory Information Management Systems in the pharmaceutical/biotech sector (or equivalent such as relevant science degree) is a plus.
  • College graduate with scientific degree and over 1 year validation experience on regulated systems would also be considered.
  • Validation experience with Watson LIMS and/or Pharsight Knowledgebase Server (PKS) systems is a large plus.
  • Some technical software development experience or database application development is also a plus.
  • This role will support senior validation analysts/specialists who have 5+ years experience in our Translational Sciences domain (pre-clinical/clinical/GLP/GCP).

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