JVT Advisors

Sr. Specialist, Quality Control, Equipment Support

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Location: Norwood, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length: 6 months

Job Summary: The individual in this role will focus on support and upkeep of the QC equipment lifecycle. The individual will coordinate across multi-discipline teams to meet business objectives and may support Investigations for Quality Events.

 

Responsibilities:

  • As part of the QC team, your primary responsibilities will be as follows:
  • Monitor and communicate Instrument lifecycle (asset induction, move/decommission, CQV activities, etc.) timelines using project management tools
  • Serve as the point person in QC for all equipment inquiries and relay to appropriate vendors as well as onsite support
  • Support instrument/equipment needs of QC laboratory including the Microbiology, Analytical, and Sample management, Raw Materials departments
  • Manage and own quality systems records such as deviations, change controls, CAPAs from start to finish
  • Support efforts for method troubleshooting, remediation, change, and optimization efforts in cross functional teams
  • Author, update, and maintain Equipment/Instrument SOPs

Requirements:

  • Minimum education required: Bachelor’s degree in relevant sciences and 3-10 years of industry experience in a cGMP laboratory setting. Level determined by experience
  • Strong technical background in Microbiology and/or Analytical Instrumentation/Software, Metrology, method acquisition and instrument troubleshooting.
  • Demonstrate ability to problem solve, organize, and see-through project timelines independently
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
  • Strong technical writing skills, oral communication and organizational skills.

Eric Carmody

Business Development Manager Life Sciences

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