Senior Analyst, Quality Control (EM &Micro) 2nd Shift
Core
Subject Matter Expert for Environmental Monitoring (EM) and Microbiology testing in a cGMP facility, ensuring product quality and regulatory compliance.
Role type
Senior IC Quality Control Analyst (Microbiology/EM)
Builds
QC testing results, validated methods, and regulatory-compliant manufacturing processes for gene therapies.
Domain
Biotechnology / Gene Therapy / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology lab techniques (Bioburden, Endotoxin, Sterility, Growth Promotion), Environmental Monitoring (air/surface sampling), SOP/Protocol writing, Deviation/CAPA management, LIMS/Veeva Vault proficiency, Risk assessment, Mentorship
Preferred skills
Leading EMPQ projects, Supervising QC Microbiology labs, Regulatory inspection experience, Advanced risk assessment tools
Technologies
Veeva Vault, Trackwise, JMP, LIMS, NetSuites
Responsibilities
Serve as SME for EM and Microbiology testing troubleshooting and method enhancement; Establish and monitor testing timelines for Bioburden, Microbial ID, Bubble point, Endotoxin, Sterility, pH, Osmolality, and Biological Indicators; Oversee scheduling and release of QC Buffer testing; Perform and review laboratory investigations, deviations, change controls, and CAPAs; Assist with validation activities (APS, hold time, BI, BB, Sterility); Provide technical guidance and training to junior analysts; Support regulatory and client inspections and internal audits.
Seniority
Senior, hands-on IC with mentorship responsibilities