Job Details

  • Title: Change Control Associate
  • Code: RCI-BMS-27867-1
  • Location: Pennington New Jersey (NJ) 08534
  • Posted Date: 07/09/2019
  • Duration: 6 Months
  • Status: Open
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  Job Description

  • Provide overall validation and documentation support for the GxP biologics laboratory areas of Biologics Development.
  • Provide support and assistance with the change control program through equipment qualifications and SOP review for and laboratory systems.

Major Duties & Responsibilities:

  • Perform review of SOPs pertaining to laboratory systems.
  • Provide input on changes pertaining equipment, computer systems and support change control program.
  • Perform the review and approval of relocation, commissioning, qualification and validation documents pertaining to equipment, and computer systems.
  • Assist with the execution of periodic re-qualification of instruments and review associated documents and test scripts for PCs used in GxP areas.
  • Participate in internal audits as needed.
  • Facilitate process improvement activities.

Education/Experience/Knowledge:

  • Knowledge of FDA, EU and ICH guidelines and cGMPs related to laboratory testing and product release.
  • Experience in Change Control Management
  • Understanding of Commissioning, Qualification, and Validation
  • Minimum of a Bachelor’s degree
  • GMP experience in a regulated industry
  • Familiarity with analytical laboratory testing
  • Experience in the review and approval of GMP documentation
  • Microsoft Office Applications
  • Electronic Document Management Systems (e.g., Document Control and Archiving (DCA) System)
  • TrackWise Quality Management System