Senior Analyst, Quality Control Microbiology

Umoja Biopharma is looking for a Senior Analyst, Quality Control Microbiology to perform testing and monitoring activities in support of the QC Microbiology laboratory and manufacturing areas at Umoja’s lentiviral vector manufacturing facility.

Requirements

• Perform routine Quality Control laboratory work, including environmental monitoring, clean utility sampling and testing, microbiological material qualification and maintenance, microbial identification, raw material sampling and inspection, bioburden testing, endotoxin testing, compendial testing, and container closure integrity testing
• Generate and revise Quality Control documents according to established document management processes
• Assist in the development of training materials and independently deliver training to staff for QC programs, systems, and processes
• Execute qualification/validation activities for QC laboratory equipment, instruments, and systems
• Execute internal and external method establishment (e.g., qualify, validate, verify, transfer) protocols to ensure QC readiness for production activities
• Initiate and support microbial excursion investigations related to facility and personnel monitoring programs (e.g., environmental monitoring, aseptic gowning, utility monitoring, etc.) through collaboration with other functions (Engineering, Manufacturing, MSAT, etc.)
• Apply and advance Operational Excellence/LEAN philosophy within the QC laboratories to ensure continuous improvement across all programs, processes, and systems
• Prepare, ship, and track samples to outside testing laboratories
• Perform additional duties within the Quality organization, as required

Benefits

• Competitive Medical, Dental, and Vision plans
• 401k plan through Fidelity, with a 100% match up to their first 4% deferral
• Generous Paid Time Off policy
• Employee commuter benefits
• Cell phone stipend