Senior Specialist, QA Document Control
Confirmed live in the last 24 hours
Ultragenyx Pharmaceutical
Job Description
Position Summary:
ultrafocused – Work together to fearlessly uncover new possibilities
Reporting to the Associate Director, Doc Control, the Senior Document Control Specialist will perform a wide variety of activities pertaining to GMP Document Control and Records Management for our Quality Control Labs and as needed, our Gene Therapy Manufacturing Plant. This is a critical position and will be responsible for the processing and maintaining of GxP documents and training records throughout their lifecycle.
This position is considered a Core Lab and Operations role and will require on-site presence every day at our Woburn, MA Quality Control lab
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
Responsibilities:
- Routine oversight of the document control and training systems effectiveness.
- Manage the documentation storage room.
- Organize and manage a high volume of documentation for archival in both electronic and paper-based processes
- Reviewing documents for completeness, grammar, formatting, and good documentation practices to ensure documents meet procedural and business required (e.g., appropriate metadata, references, etc.).
