Job Details

  • Title: Product Quality Specialist
  • Code: RCI-7959
  • Location: West Greenwich Rhode Island (RI) 02817
  • Posted Date: 11/24/2020
  • Duration: 6 Months
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  Job Description

75% Onsite, shift: 8-5 standard hours, and potential evenings as the process requires

  • Manage the development and implementation of clinical and commercial product specifications, in process control documents, and other specification related documents
  • Facilitation of specification development meetings and the generation of detailed and communicate meeting minutes/action items to all attendees
  • Other tasks include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner
  • Own nonconformance records (NC), and lead or coordinate activities required to advance NCs to closure
  • Implement and maintain a product quality data tracking system that facilitates meaningful analysis of release and in process test results (data mining)
  • Assisting Product Quality leader function by facilitating team meetings and drafting/distributing meeting minutes, assisting in the management of product sample plans, as well as other assignments and projects as assigned
Skills:
  • Degree in life science, business or engineering
  • Project management and/or industry experience
  • Experience using computer software such as MS Office (i.e. Excel, Word, Project)
  • GMP experience
  • Single use technology,┬áCell Culture,┬áPurification experience is nice to have
  • Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment
  • Demonstrated ability to forge and maintain strong relationships within other functional areas
  • Ability to recommend, judge, and make good decisions in complex situations
  • Ability to tactfully and effectively negotiate and influence