QC Microbiology Senior Analyst II

Responsibilities

• Serve as SME for multiple microbiological assays including bioburden, endotoxin, TOC, and conductivity
• Execute routine, non-routine, and qualification testing of in-house microbiological methods
• Review and approve cGMP analytical data from utility, release, and stability testing
• Lead QC Microbiology laboratory operations, including sample monitoring and reagent qualification
• Author quality records such as change controls, deviations, CAPAs, and OOS investigations
• Write and prepare technical reports and standard operating procedures (SOPs)
• Mentor and train junior staff and serve as a trainer for in-house methods
• Participate in regulatory inspections and support cross-functional activities

Requirements

• BS or MS in Microbiology
• 6+ years of QC experience
• Demonstrated knowledge of microbiological methods (endotoxin, bioburden, sterility, mycoplasma, etc.)
• Strong technical writing skills for GMP-compliant controlled documents
• Ability to stand for extended periods and lift up to 50lbs
• Ability to work in a lab environment requiring personal protective equipment

Preferred Qualifications

• Experience with electronic document management systems (EDMS) such as Veeva Vault
• Experience with LIMS

About the Company

Ultragenyx is a biopharmaceutical company dedicated to leading the future of rare disease medicine by following the science and applying a novel rapid development approach to create life-changing treatments.