JVT Advisors

Specialist, Quality Control Systems (2)

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length:  6+ months

Job Summary:  Reporting to the Sr. Manager, Quality Control, this individual will be responsible for facilitating rollout and assisting management of the company’s Quality Control Digital roadmap. This role will be crucial in the enhancement of QC digital operations.

Responsibilities:

  • Responsible for facilitating strategic expansion and execution of quality control digital systems and applications
  • Partner with Digital on cross functional digital lab systems projects
  • Serve as business representative for critical QC digital systems changes
  • Participate in digital system validation activities including business process analysis, test script development and execution
  • Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations
  • Collaborate with QC subject matter resources to coordinate implementation of changes

Requirements:

  • BS/BA and minimum, 5-7 years or MS with 3+ experience in cGMP environment; 2 - 4 years in a lab analyst role
  • In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations.
  • Experience with various digital quality systems such as LIMS, Lab Execution System, SDMS
  • Strong knowledge of digital quality systems (LIMS, QMS, CDS) preferred.
  • Experience with system validation
  • Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively.

 

 

Trevor Hoffman

Technical Recruiter

Trevor recruits for JVT's Life Sciences and Technology Practices where he specializes in finding, screening, and placing top-tier industry innovators at companies across multiple markets and verticals.

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