Manufacturing Document Reviewer

United States, Houston (Texas)

Document Systems Reviewer

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 Cell and Gene Therapy Facility is the largest in the world and is still growing. We are looking for professionals to grow with us and we have this exciting opportunity in Viral Vector Therapy.  

The Document Systems Reviewer in Viral Vector will be responsible for the review of assigned manufacturing documentation and driving the subsequent corrections needed, prior to Quality review of each document and for escalations to senior members and Supervisors of the team for complex issues that arise during review within Viral Vector Manufacturing.

Key Responsibilities:

  • Independent review and driver of associated corrections pertaining to manufacturing Good Manufacturing Practice (GMP) records.

  • Review will be performed independently with minimal direction for the review process.

  • Simple issues found during the review of documentation should include identification of documentation errors.

  • The Reviewer can identify when a nonconformance has occurred.

  • Escalate issues to Supervisors for mentoring through the process to gain the information required to make the appropriate decision.

  • Maintain document organization in specified document control area.

  • Update and maintain document review tracker.

  • Train junior level reviewers and provide guidance as necessary

Key Requirements:

  • Bachelor’s degree in Life Sciences or Associates Degree with relevant experience required.

  • Familiarity with cGMP quality systems.

  • Ability to read and comprehend GMP documents (i.e. SOPs, logs, and Batch Records).

  • Strong organizational skills and record keeping with the ability to work overtime when needed.

  • Ability to review large volumes of documents thoroughly in a timely manner and follow up with personnel to correct any errors found.

  • Strong attention to detail and organizational skills.

  • Strong communication skills (written and oral).

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: R35437