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
