March 2nd, 2018

Quality Documentation Job – Temp, Irvine, CA

Quality Documentation JobOur client has a temporary quality documentation job in Irvine CA estimated to last for 12 months.

Minimum Qualifications:

  • Two-year degree: Science, Chemistry or Biology and/or related field preferred.
  • Two to four years related experience. Working in a laboratory environment in a pharmaceutical, medical device or related industry including Quality Assurance preferred.

Desired Skills

  • Different computer software such as Microsoft Word, Excel, Access, Visio, Power Point, and Outlook preferred.
  • Computerized systems such Documentum, Trackwise, and SAP preferred but not required.
  • General cGMP, ISO 13485, and FDA/MOH Requirements preferred but not required.
  • General knowledge of pharmacopeias preferred but not required.
  • Project management software.

Quality Documentation Job Duties

  • Coordinates and processes all Master Specifications and Documentation-managed documents through the Change Control process/system with supervision as necessary.
  • Assists with word processing Master Specifications and Documentation SOPs as needed.
  • Assists in processing Product Launch Approvals (PLAs) and PLA Amendments as completed documents in CORAL.
  • Effectively communicates (written and verbal) with colleagues at most levels of the organization to achieve timelines for project completion.
  • Keeps project records organized to allow others within the Master Specifications and Documentation department to take over if necessary.
  • Assists the Master Specifications and Documentation department as needed.

Note that many of the functions of this quality documentation job are applicable for those interested in earning their Certified Quality Improvement Associate (CQIA).

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Paul Dionne
Talent Manager
MEIRxRS 818-552-2625

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