Location: 
Fall River
Employment Type: 
Contract
Job ID: 
134085
Description: 

This is a contract role until the end of July, with some possibility of extension.

Entry-level opportunity to gain more experience!

The QA Document Control Specialist II (TEMP) supports Quality Assurance functions focused on GXP documentation. The position maintains GLP document control and training systems.

Position Responsibilities:

•     Maintain GLP document control system including preparing, updating, formatting, distributing, issuing, and tracking GLP documents.

•     Maintain GXP record retention program for archiving raw data, archiving documents on site and managing off site QA documentation storage.

•     Manage, distribution and reconciliation of laboratory notebooks

•     Manage GXP training database and periodic reports

•     Provide GXP training, as needed

•     Trend and report QA Document Control information

•     Perform other ·ob-related functions

Required Skills:

  • Working knowledge of EDMS (electronic document management system)
  • Strong working knowledge of cGMP or GLP.
  • Strong working knowledge of MS Word, Access, Excel and related databases. Excellent communication  skills.
  • The ability to work independently and as part of a team

Education/Experience:

·                  Bachelor Science (BS) degree or equivalent experience

·                  1-3 years QA experience in Biotech/Pharma industry.

 

Keywords:  Quality Assurance, Documentation, GLP

 

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