Quality Issue Management Specialist (QIM)

Princeton, NJ
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Type: Contract

Category: Scientific & Clinical

Job ID: 142088

Date Posted: 06/14/2019


Title: Quality Issue Management Specialist (QIM)

Location: Princeton, NJ

Schedule: Mon - Fri, 8:30am - 4:30pm

Type: Temp with possible extension

Start Date: 07/01/2019 or asap

Responsibilities

  • Support the implementation and maintenance of an innovative Quality Issue Management (QIM) system for U.S. Marketed Products that is compliant to all applicable Health Authority regulations, effective, efficient and agile.  The QIM System will enable the client to capture a range of quality isssues, process them by instigating suitable quality activities and monotor the processing status throughout the entire resolution process
  • Be tje Quality point of contact for Marketed products (U.S. scope), i.e.
    • Tech transfer Quality support
    • R&D release meeting (RTM and RTS)
    • PTR Quality Contact
    • Change Controls quality contact
  • Align SME globally on new tools based on 8D investigation roadmap
  • Manage and monitor the QIM globally (Plants, Division and Corporate) to ensure alignment and respect deadlines
  • Escalate areas of non-compliance, risk and/or potential improvement to Management and develop plans for appropriate action to address causes of deficiencies
  • Identify and investigate potential trends for improvement initiatives
  • Interact with the others Dpt to create a team for supporting the resolution
  • Interact with the others Dpt to share trend, result and align stakeholders on expectations

Requirements

  • BA / BS Degree in Science, Business, or related (or as long as years' of experience is directly related to responsibilities)
  • Senior level role with approximately 10 years of experience
  • Must hit the ground running
  • Must have strong proficiency in Marketed Products within the U.S. and QIM Quality Issue Management
  • Role will start primarily on site, but must be ok to travel approximately 0-20% to start off pending issues management

 

 


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