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Specialist Product Quality (JP7959)

West Greenwich, Rhode Island · Biotech/Pharmaceutical
Job Title: Specialist Product Quality (JP7959)
Location: West Greenwich Rhode Island 02817
Employment Type: Contract
Duration: 6 months (no extensions)
Job posting date: 24 November 2020
Note: working on site 75% of the time, 8-5 standard hours, and potential evenings as the process requires

3 Key Consulting is hiring a Specialist Product Quality for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
  • 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).
  • Additional responsibilities include 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).
  • Education: Bachelor's Degree in Engineering or Scientific Field
Top Must have Skill Sets:
  • GMP experience
  • Single use technology experience
  • Cell Culture Experience
  • Purification experience
  • Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment
  • Strong project management skills with ability to multi-task and function in a dynamic environment
  • Excellent communication skills, drive, and sense of urgency
  • 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.
Day-To-Day Responsibilities:
  • Supporting Manufacturing
  • SOP, Deviation,
  •  Documentation ownership,
  • trouble shooting of manufacturing processes,
  •  root cause analysis
Employee Value Proposition: working on a new product introduction
Red Flags:  No experience with GMP or Manufacturing
Interview Process:
Phone/Video Call 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team

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