Sr. Specialist, QA Document Control
Ultragenyx Pharmaceutical Inc.
Quality Assurance
Woburn, MA, USA
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.).
- 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
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.
#LI-CT1 #LI-Onsite
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.