Company:  Confidential

Job Title: QA Documentation Specialist

Job Number: 24509

Location: Needham, MA

Job Description

We are seeking a contract Document Control Specialist to support Quality Assurance functions focused on GXP documentation. The position maintains GLP document control and training systems.


Responsibilities include:

  • 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 job-related functions

Required Skills

  • Bachelor Science (BS) degree or equivalent experience
  • 1-3 years QA experience in Biotech/Pharma industry.
  • 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


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