Sr. Specialist, QA Document Control

Ultragenyx Pharmaceutical•Woburn, MA

2d•Onsite

About The Position

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

Requirements

BS in related field with 6+ yrs. experience, science degree preferred
Direct experience in document control, quality systems and training
Experience with e-DMS systems in pharmaceuticals and/or medical device (experience in Veeva Vaults preferred)
Demonstrated working knowledge of GxP quality systems requirements
Working knowledge of ICH/GxP regulations and expectations
Strong attention to detail is required.
A team player with excellent cross-functional partnership skills and proven track record to work across the organization. Collaborates and communicates transparently, listening and understanding effectively, and inviting response and discussion with key stakeholders.
Strong knowledge of MS Word and MS Excel is required. Understanding of creating fillable forms in Adobe is a plus.
Must be independent, self-motivated, organized, able to multi-task and skilled in communication. Ability to plan, organize and execute multiple documents and tasks simultaneously.

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.).
Perform administrative tasks for electronic document/training management systems, including issuance of new accounts, revising user access levels, and updates to system set-up
Issuing/Reconciling Controlled Documents
Issuing/Reconciling Periodic Review Tasks
Reporting and monitoring Document Control Metrics to ensure compliance within Ultragenyx processes and procedures
Write, review, and approve SOPs in an area of expertise.
Retrieval of documentation upon internal customer request
Provide Document Control support in preparation of, during and after internal or external Audits/Inspections