Project Lead, Document Control, eDMS
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, located in Houston Texas, is the largest in the world and our facility is growing. We are seeking to add top talent to our Quality Assurance Document Control team. The Project Lead Document Control, eDMS will lead the Electronic Document Management System(eDMS) Document Control team and serve as representative on site project teams in order to cross functionally communicate customer and quality requirements.
- Lead the document change request process of all controlled documents for all functional areas.
- Serve as the master work planner for the eDMS team. Communicate and track upcoming project deliverables and timelines.
- Perform final formatting edits of controlled documents to ensure compliance with local/global templates and initiate/manage subsequent workflows in Documentum.
- Assist in the development and use of document templates.
- Serve as SME of Documentum in the role of QM1 system administrator.
- Perform eDMS troubleshooting/configuration improvement tasks for the site.
- Train and assist other employees with Microsoft Office and eDMS use.
- Own and approve eDMS team related quality records such as: Deviations, CAPAs, Change Controls, etc.
- Manage and track Key Performance Indicator (KPI) quality metrics for the eDMS team.
- Continually evaluate opportunities for improvement to increase efficiency while ensuring compliance to applicable regulatory requirements and standards.
- Author/revise relevant procedures as needed. Develop and deliver training regarding departmental process and system changes.
- Cross-train and support all other areas of Document Control including controlled document/logbook issuing process, record archival management, and any other process and procedure related to document control.
- Support customer audits and inspections.
- Perform other duties as assigned.
- Bachelor’s degree plus senior experience within biotechnology industry
- Experience with cGMP and regulations (US, EU and others), Project Management Skills, Problem Solving Tools, Lean/Six Sigma methodologies, Technical Writing, TrackWise, Learning Management Systems (LMS), Document Management Systems (DMS), SAP.
- Advanced computer software skills including, Microsoft Office. Proficient in the use of spreadsheets, databases, presentation, and word processing software.
- Filing, organization, record keeping and planning skills; ability to manage multiple projects concurrently; time management skills.
- Written and oral communication skills, listening skills, independent and self-directed, team-oriented.
- Ability to interact effectively with staff members from multiple levels and departments.
- Self-motivated, works well independently and as a team player.
- Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time
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.