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← Ultragenyx Pharmaceutical

Senior Specialist, Quality Assurance Operations

Ultragenyx Pharmaceutical
Location
Bedford, MA
Posted
20 days ago
Department
Ultragenyx Gene Therapy - Quality Assurance Operations
What they actually want (must-haves)
  • Minimum B.S. degree in scientific field such as microbiology, chemistry or biochemistry
  • 5+ years of experience in biopharmaceutical, biotechnology, cell or gene therapy industries with Manufacturing and Quality roles
  • Direct experience working at a biologic or advanced therapy medicinal product (ATMP) manufacturing site
  • Knowledge and experience with drug substance and aseptic practices
  • Knowledge of domestic and international GMP regulations and their application in the manufacture of biologics, cell, or gene therapy products
  • Demonstrated ability to communicate technical information or complex situations to site management and/or health authority inspectors in a concise and clear manner
What the job really is

In this role as a Senior Specialist in Quality Assurance Operations, you will oversee QA activities at a gene therapy manufacturing facility, focusing on drug substance manufacturing. Your daily tasks will include reviewing production batch records, managing deviations, conducting QA walkthroughs, and collaborating with various departments to ensure compliance with GMP regulations. The position requires a commitment to quality and continuous improvement in a multi-product environment.

Benefits
  • 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
Things to weigh
  • Position requires on-site work in a controlled environment with specific gowning and safety protocols
  • Physical demands include standing for extended periods, lifting up to 50lbs, and working in temperature-controlled environments
  • Work schedule is Wednesday to Saturday with flexibility in start times, which may not suit everyone
Job score3.2/5
Benefits4/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

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