QC Microbiology, Senior Analyst II

Position Summary:

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Reporting to the QC Microbiology Director, the Senior QC Analyst II will support the Ultragenyx gene therapy program pipeline through oversight, review and/or execution of GMP microbiological assays including but not limited to endotoxin, bioburden, conductivity, total organic carbon (TOC) testing, growth promotion, sterility, mycoplasma, container closure integrity testing (CCIT), and in vitro adventitious agent (IVAA) testing.  This position is responsible for scheduling laboratory activities and ensuring testing is completed on time and in a compliant manner. 

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

1. SME for multiple microbiological assays (e.g. bioburden, endotoxin, TOC, conductivity, growth promotion, etc.). 
2. Execute routine, non-routine, and qualification testing of in-house microbiological methods. 
3. Review and approve cGMP analytical data from utility, release, and stability testing for internally and externally generated data. 
4. Support and lead QC Microbiology laboratory operations (e.g. monitor incoming samples, schedule microbial testing and qualification of critical media and reagents, ensure QC data packets and logbooks are reviewed within required timelines, etc.). 
5. Independently own and author quality records including change controls, deviations, CAPAs, invalid assays, excursion investigations, OOS Investigations, etc. with minimal managerial oversite. 
6. Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs).  
7. Serve as trainer for in-house microbiological methods. 
8. Lead, or participate in, the development of new methods.  
9. Model leadership behaviors and mentor/train junior staff.   
10. Work with internal/external personnel within and outside area of expertise to support cross functional activities. 
11. Participate in regulatory inspections. 

Requirements:

1. BS or MS in Microbiology with 6+ years of QC experience. 
2. Demonstrated knowledge of microbiological methods including endotoxin, bioburden, conductivity, total organic carbon (TOC) testing, growth promotion, sterility, mycoplasma, container closure integrity testing (CCIT), and in vitro adventitious agent (IVAA) testing. 
3. Strong technical writing skills with demonstrated experience in controlled document generation in accordance with GMPs. 
4. Experience with electronic document management systems (EDMS) such as Veeva Vault and LIMS is preferred. 
5. Strong collaboration and communication skills. 
6. Independently motivated and detail-oriented with good problem-solving ability. 

Physical Demand Requirements:

• Stand for extended periods of time with periodic stooping / bending / kneeling 

• Able to lift, push, pull up to 50lbs. 

• Climb ladders and stairs of various heights. 

• Work in a lab environment requiring special protective clothing over the head, face, hands, feet, and body. This role requires the ability to wear personal protective equipment. 

• Certain tasks may require use of a respirator; medical clearance will be required in advance.  

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