PPD Microbiology Job Opening – Lead Quality Investigator

PPD Microbiology Job Opening – Lead Quality Investigator

Thermo Fisher’s clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Job Title: LEAD QUALITY INVESTIGATOR

Location: FSP New Brunswick NJ – New Brunswick – NJ

Education and Experience: 

  • Bachelor’s degree in Microbiology, or equivalent and relevant formal academic/vocational qualification Master’s Degree a plus
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

Essential Functions:  

  • Leads multiple CAPAs, investigations (including laboratory investigations), or proactive initiatives for complex, multidisciplinary, multi-site, analytical and microbiological Root
  • Cause Analyses across the Analytical Quality Control network internal and external
    Owns deviations as appropriate and supports the subsequent Notification to Management process as required
  • Serves as a Subject Matter Expert for Root Cause Analysis and Microbiology as requested to support network investigations
  • Represents the organization as a technical expert for projects and initiatives
    Designs complex technical projects or investigations, interprets diverse data and/or results, and independently recommends next steps
  • Leverages Operational Excellence principles, Lean principles, and Quality Risk
  • Management principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste across the enterprise
  • Regularly adapts standard Root Cause Analysis methods and techniques to unique investigations, using expertise to select the best-in-class approach
  • Recommends novel solutions and makes decisions that solve complex problems identified in investigations. Solutions improve the ability of a team to deliver on its objectives and meet the needs of colleagues
  • Interfaces with internal and external auditors during plant inspections as needed to support investigations
  • Works independently as a Lead Investigator, Subject Matter Expert for Root Cause Analysis, or Project Manager
  • Demonstrates cultural values and influences others to apply business values of trust, accountability, and inclusion
  • Remains engaged with current industry standards, trends, and regulatory expectations by participating in training and industry conferences
  • Manages multiple AS&T projects or programs, as appropriate. Facilitates teamwork and coordinates execution of plans with key colleagues

PPD Microbiology Job Opening

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