Senior Quality Control Analyst I at Ultragenyx in Woburn, MA

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:

ultradedicated – Your biggest challenges yield rare possibilities

This position is in the Ultragenyx Gene Therapy Quality Control Systems group. The primary function of the Quality Control (QC) Senior Analyst I will be to maintain the QC Laboratory Information System (LIMS). The individual will work with others in IT and Quality Management to ensure the QC LIMS system maintained in a state of compliance. Routine work includes partnering with IT, Quality and the LabVantage team to configure, create master date and validate LIMS workflows used in the QC Laboratory. Additionally, this position will support the administration of the Learning Management System (LMS) as it pertains to the UGT Quality Control organization.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

LabVantage LIMS Quality system management and administration including, but not limited to, product builds, change management to approved master and transactional data, authoring and execution of UATs, maintenance of routine schedules (e.g. environmental monitoring and stability) as needed.
Maintain and deliver end user training and support for daily operation.
Management of user access requests and account setup/configuration.
Lead projects that update and/or expand LabVantage LIMS system.
Manage the Learning Management System (QC) as it pertains to UGT Quality Control, as needed.
Support the QC Systems leadership and IT in defining and executing the strategy for LIMS at UGT.
Keeps customers / requestors informed of the status of work, schedules, completion, and closeout, including soliciting feedback from the end user to support continuous improvement.
Work with cross-function teams including, but not limited to, Quality Assurance, Manufacturing and Information Technology.

Requirements:

Bachelor’s or Master’s degree in Biology, Chemistry or equivalent
Minimum 5-8 years of experience in the biotech industry
Experience with Laboratory Information Systems (LabVantage preferred).
Demonstrated written and oral communication skills at individual, team and organizational levels are essential.
Possesses strong time management skills
Experience working on cross-functional teams and managing relationships in collaborative, constructive manner with internal stakeholders required,
Independently motivated, detail oriented and strong problem-solving ability #LI-HYBRID #LI-AJ1

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.

Pay Range$96,300—$119,000 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · Generous vacation time and public holidays observed by the company · Volunteer days · Long term incentive and Employee stock purchase plans or equivalent offerings · Employee wellbeing benefits · Fitness reimbursement · Tuition sponsoring · Professional development plans * Benefits vary by region and country

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.

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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.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.