Sr. Specialist, QA Document Control

Ultragenyx Pharmaceutical•Woburn, MA

1d•Onsite

About The Position

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: ultra focused – 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.

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.
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.

Nice To Haves

Understanding of creating fillable forms in Adobe is a plus.

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