Quality Specialist

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Irvine, CA
$1 - $1
$1.00 - $1.00
Job Type
Bachelor of Science
Nov 13, 2018
Job ID
The candidate is responsible for expeditiously developing and processing raw material and product documentation to meet quality requirements within timelines established for product launch and/or timely project completion.The Master Specifications
and Documentation department interacts with various Pharmaceutical groups within the organization and departments such as Quality, Global Pharmaceutical Technology, Regulatory Affairs, Operations, Manufacturing (all sites), Procurement (Sourcing),
and Research and Development (all phases) and with our affiliates/contractor sites on possible “Change Control” related issues. 

Coordinates and processes all Master Specifications and Documentation-managed documents through the Change Control process/system
Assists in processing Product Launch Approvals (PLAs) and PLA Amendments as completed documents 
Assists with word processing Master Specifications and Documentation SOPs as needed.

BS: 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
Knowledge of general cGMP, ISO, and FDA Requirements

All applicants must have authorization to work in the U.S.