Sr. Specialist, QA Document Control

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

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:

1. Routine oversight of the document control and training systems effectiveness.  
2. Manage the documentation storage room.  
3. Organize and manage a high volume of documentation for archival in both electronic and paper-based processes 
4. Reviewing documents for completeness, grammar, formatting, and good documentation practices to ensure documents meet procedural and business required (e.g., appropriate metadata, references, etc.).  
5. Perform administrative tasks for electronic document/training management systems, including issuance of new accounts, revising user access levels, and updates to system set-up 
6. Issuing/Reconciling Controlled Documents 
7. Issuing/Reconciling Periodic Review Tasks 
8. Reporting and monitoring Document Control Metrics to ensure compliance within Ultragenyx processes and procedures 
9. Write, review, and approve SOPs in an area of expertise.   
10. Retrieval of documentation upon internal customer request  
11. Provide Document Control support in preparation of, during and after internal or external Audits/Inspections 

Requirements:

1. BS in related field with 6+ yrs. experience, science degree preferred 
2. Direct experience in document control, quality systems and training 
3. Experience with e-DMS systems in pharmaceuticals and/or medical device (experience in Veeva Vaults preferred) 
4. Demonstrated working knowledge of GxP quality systems requirements 
5. Working knowledge of ICH/GxP regulations and expectations 
6. Strong attention to detail is required. 
7. 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. 
8. Strong knowledge of MS Word and MS Excel is required. Understanding of creating fillable forms in Adobe is a plus.  
9. Must be independent, self-motivated, organized, able to multi-task and skil