• Job Description

  Req#: R54569

  Today Lonza is a global leader in life sciences. 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 – eDocs will represent the QA department on project teams and improvement initiatives , ensuring that quality requirements are met. Also r esponsible for performing document control duties such as the management of workflows, processing change request s for controlled documents (SOPs, Batch Records, Forms, etc.) , all with in an electronic document management system. Support other quality systems such as controlled print copy issuance, records management, deviations, CAPAs, audits, change controls and training, as needed. Also responsible for filing and archiving quality documents.

  Key responsibilities:

  • Assist with the administration of the Electronic Document Management System (Documentum) as a QM1 system administrator.
  • Initiate/manage workflows, perform final formatting edits of documents, assist/train other employees on use of the system, and perform system troubleshooting/configuration improvement tasks.
  • Lead site-wide training for QMS systems for NHO and role-specific training.
  • Support and manage the document change request process. Provide improvement recommendations.
  • Support internal / external audits by copying, scanning and distributing various documents as needed
  • Perform records management tasks such as filing, scanning, archiving, and providing electronic copies of archived record requests.
  • Perform the Quality Assurance review and approval of Document Control records including change controls, deviations/ investigations, CAPAs and controlled documents.
  • Cross-train with other members of the Quality Systems group to serve as back up for other Quality Systems functions as needed, including deviations review board, change review board, learning management system, etc.

  Key requirements:

  • Bachelor’s degree and experience with word processing particularly related to manufacturing / validation documentation and Standard Operating Procedures.
  • Experience with cGMP and 21 CFR P art 11 compliance knowledge.
  • Advanced c omputer software skills including, Microsoft Office. Other EDMS experience helpful. Proficient in the use of spreadsheets, databases, presentation, and word processing software.
  • Advanced technical writing skills and proficiency with Word, Excel, PowerPoint, etc. required .
  • Excellent written and oral communication skills, listening skills, independent and self-motivated, but team-oriented, with the ability to interact effectively with staff members from multiple levels and departments.
  • Experience working in a customer support role with many different departments and personnel levels.
  • Must have strong organizational skills and be able to manage and prioritize multiple assignments with tight turnarounds, while adjusting to changing demands and directives
  • Strong ability to troubleshoot and problem-solve
  • Team player but also, must be a self-starter, highly motivated and willing to take initiative with process improvements.
  • Able to follow directions precisely and very detail oriented

  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.

Notice