5050 Technical Change Management Documentation Specialist
Coordinate and document technical changes for Technical Transfer & Capital Projects in Veeva.
Coordinate and execute document changes for Technical Transfer & Capital Projects projects.
Coordinate, execute and document Design Qualification for Technical Transfer & Capital Projects projects.
Draft change records and document deliverables in Veeva.
Execute document changes in Syncade and Veeva.
Manage, generate, modify, and support GMP documentation and drawing changes.
Update/report completion in project schedule.
Export data and create metrics/charts to report status.
Ensure deliverables are completed and documented in time to meet project milestones.
Review all project GMP documentation.
Assist in the change control process in accordance with existing procedures and new documentation processes as they are developed.
Assist with generation of project workflows.
Assist with generation of project work instructions.
Assist with generation of project schedule templates.
Lead project meetings and generate meeting agendas and minutes.
Assist with generation of business processes.
Translating ideas into specifications, work instructions, and standard operating procedures.
Strong Knowledge of Good Manufacturing Practices.
Strong Technical Writing Skills.
Troubleshooting & Problem-Solving.
Gathering, Collating, Assimilating Information.
Working with Teams to Complete Projects.
Organizational & Analytical Abilities.
Attention to Detail, Goal-Oriented Focus.
Ability to Seek and Use Input from Target Audience.
BS degree with a minimum of 6 years experience.
An advanced degree (MBA or MS) is a plus.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.