Sr Specialist, QA Document Management

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Reporting to the Director of Quality Systems and Compliance at the Gene Therapy Manufacturing Site, the Quality Systems Document Control Sr. Specialist will perform a wide variety of activities pertaining to GMP Document Control and Records Management. This is a critical position and will be responsible for the processing and maintaining of GxP documents and training records throughout their lifecycle.  This role will also participate in improving Ultragenyx’s GxP Quality Systems.

This position is considered a CORE role and will require consistent on-site presence.  It will initially be based at the new Gene Therapy Manufacturing Therapy (GTMF) location in Bedford, MA.  

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.).
• 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 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

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 on multiple documents and tasks simultaneously.