• Job Description

  Req#: R54150

  Today, Lonza is a global leader in life sciences operating across three continents. 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.

  Lonza’s Houston, Texas site has an exceptional opportunity within our Quality Management Systems Team for a Quality Assurance Specialist Level IV. This individual will be responsible to provide overall supervision of Quality Systems including change control, deviation, CAPA and effectiveness check systems. This position will ensure implementation of effective and timely change controls, deviations, CAPAs and effectiveness checks in collaboration with all assets and functions at the site. The individual will support maintaining a program of continuous inspection readiness.

  Key responsibilities:

  • Supports the execution of the change control, deviation, CAPA and effectiveness check systems.
  • Supports and trains site subject matter experts (SMEs) in how to execute change control, deviation, CAPA and effectiveness checks.
  • Responsible for coordinating the site’s change control, deviation, CAPA and effectiveness check programs.
  • Acts as a SME in how to execute compliant change control, deviation, CAPA and effectiveness checks.
  • Functions as a TrackWise SME related to the change control, deviation, CAPA and effectiveness check modules.
  • Supports and hosts change controls review board, deviation review board and CAPA review board.
  • Supports as a SME related to the change control, deviation, CAPA and effectiveness check systems in customer and Health authority inspections.
  • Provides KPIs for change control, deviation, CAPA and effectiveness check systems.

  Key requirements:

  • Bachelor’s Degree or Master’s Degree required in Life Sciences, Engineering, Quality Management or related science discipline
  • Advanced experience (5-10 years) in biopharmaceutical manufacturing experience and/or quality operations plus quality systems working in a GMP environment
  • Solid experience with change control, deviations and CAPA’s
  • Experience with TrackWise
  • Experience with Health Authority Regulations (US FDA, EMA, MHRA, etc.)
  • Experience in an aseptic manufacturing environment

  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.

• About the company

  Lonza Group is a Swiss multinational chemicals and biotechnology company, headquartered in Basel, with major facilities in Europe, North America and South Asia.

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