QA Specialist - Document Control

United States, Houston (Texas)

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.

The QA Specialist - Document Control, eDMS will contribute to the development, implementation and maintenance of electronic Document Management Systems (eDMS) processes and activities.  Responsible for performing document control duties such as management of workflows and change requests of controlled documents (SOPs, Batch Records, Forms, etc.) in an electronic documentation management system, ensuring documents conform to local and site standards/templates, and completing assignments that are complex in nature where judgment is required in resolving problems and making recommendations.  

Key Responsibilities:

  • Analyze document change requests for completeness.  Ensure the correct and timely implementation of document change requests
  • Achieve and maintain SME status on all functional area application systems and reporting tools such as Documentum.
  • Train and assist other employees on eDMS processes and Documentum use..
  • Create and maintain document templates while ensuring continuous improvement.
  • Initiate/manage workflows, perform final formatting edits of documents for consistent formatting and adherence to site/global templates
  • Perform advanced word processing support and support and assist document authors in resolving complex document formatting issues
  • Perform Documentum troubleshooting/configuration improvement tasks.
  • Write, review and revise site procedures related to electronic document management systems and ensures their proper implementation
  • Support the collection and maintenance of eDMS department process metrics to Quality Management up to Site Quality Leadership for review
  • Support the document periodic review process.
  • Perform the Quality Assurance review and approval of electronic document control related quality records such as: deviations, CAPA, change controls, SOPs, training, etc.
  • Develop and implement process improvements.
  • Develop and lead special projects as requested.
  • Support internal, external and regulatory audits and inspections.
  • Cross-train with other members of the Document Control group to serve as back up for other Document Control functions as needed, including document issuance and records management.
  • Perform other duties as assigned.

Key Requirements:

  • Bachelors degree and experience within cGMP environment
  • Advanced cGMP and 21CFR Part 11 compliance knowledge
  • Advanced computer software skills inlcuding Microsoft Office. Other EDMS experience preferred
  • Filing, organization, record keeping and planning skills; ability to manage multiple projects concurrently; time managment skills
  • Written and oral communication skills, listening skills, independent and self directed
  • Ability to interact effectively with team members from multiple levels and departments

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: R43481