Quality System cGMP/QA specialist cGMP Consultant

Overview

Contract - W2
Contract - 12 month(s)

Skills

cGMP/FDA
QC or QA.
QMS)
electronic documentation management systems (EDMS) and inventory management systems.

Job Details

Role: Quality System/QA specialist

Location: Watertown, MA hybrid (2 to 3 days onsite and remote)

Job Description:

  • experience in a cGMP/FDA regulated environment such as Manufacturing, QC or QA.
  • Knowledge of cGMP and applicable FDA/international regulations.
  • Direct experience with plant operations, pharmaceutical/biotechnology manufacturing and analytical testing a plus.
  • Experience working with clinical and/or commercial products.
  • Detail oriented team player with effective planning, organization, and execution skills.
  • Excellent communication skills with internal and external personnel essential.
  • Ability to work effectively at a fast pace with cross functional departments.