Demo

QA Compliance Specialist- Change Control, Deviations, CAPA

IntePros
Brunswick, NJ Full Time
POSTED ON 2/8/2025
AVAILABLE BEFORE 5/8/2025

Our major pharmaceutical client is in need of a QA Compliance Specialist to manage and provide oversight for their Quality Systems reviews, change control, deviations investigations and CAPA requirements. They have 25 separate buildings / labs on this campus in central, NJ.

Requirements :

Having worked with pharmaceutical facilities and utilities maintenance related environments managing, tracking, recording and addressing Change Controls, Deviations and CAPA

  • Change control understanding and working through an entire process
  • Build and create environment moving forward, working directly with onsite deviation teams and help them manage Change Control properly.
  • Assist with overseeing inefficiencies / deviations, helping to reduce backlog of deviations of their QMS environment.
  • Perform investigations / execution of the backlog while identifying risk and write up the deviations accordingly.
  • Managing change control records, and updating them when new ones occur.

Requirements :

  • Bachelor Degree Engineering / Mechanical or industry related
  • 5-10 years experience with deviation and CAPA management systems in the pharm industry
  • Must be independently thinking consultant who can analyze the investigations / deviations they're managing and have the experience to understand if they are successfully making change or not.
  • Having worked with QMS environments like Veeva / Trackwise, etc.
  • Infinity preferred
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