Quality Records Investigator

United States, Houston (Texas)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Quality Records Investigator will be  responsible for tracking, management, and completion of Quality Control Quality Records (such as deviations, lab investigations, change control, and CAPA) in partnership with applicable Subject Mater Experts. Leads error prevention and continuous improvement initiatives based on identified recurring root cause.

Key Responsibilities:

  • Serves as the Quality Record (PR) Subject Matter Expert (SME) for the Quality Control team
  • Leads complex technical investigations independently with occasional guidance and support
  • Drives closure of Quality Records by completing records per defined Standard Operating Procedures (SOPs) or by providing coaching and mentoring to record Authors and Contributors
  • Reviews and approves records for quality and consistency to ensure Right-First-Time approval by Quality Assurance and on-time closure of records
  • Monitors, analyzes and reports on quality record trends for the functional area to reduce non-conformance occurrences and recurrence over time
  • Utilizes quality record data trends, cGMP knowledge and Lean Six Sigma philosophy (i.e. Gemba Walk, 5 Why’s, Pareto Analysis)  to actively identify, drive and implement continuous improvement / error prevention initiatives within the functional area
  • Provides training on Root Cause Analysis to record Authors and Contributors as necessary
  • Works on or leads other projects related to Error Prevent in response to identified CAPA
  • Performs other duties as assigned.

Key requirements:

  • Bachelor’s Degree in Scientific Discipline.
  • Experience performing root-cause analysis, leading, and completing lab investigations
  • Prior experience working in a laboratory setting required
  • In-depth knowledge of cGMP principles.  Able to identify breach of cGMP principles and provide suggested corrective actions. 
  • Proficient in the use of spreadsheets, databases, and word processing software.
  • Prior experience with TrackWise preferred
  • Able to propose ideas during problem solving, root cause analysis, and process improvement events.  Provides suggestions for improvement to documentation and workflows
  • Capable of effectively representing the department in meetings and on project teams.  Provides timely, clear, and accurate updates without being prompted
  • Is optimistic and displays a positive attitude even during periods of adversity.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R26084