Lab Analyst II
Core
Conduct analytical QC testing and method validation for clinical studies using HPLC and various laboratory instruments to ensure data integrity and regulatory compliance.
Role type
Senior IC QC Lab Analyst
Builds
Analytical test results and validated methods for clinical research
Domain
Healthcare / Clinical Research / Bioanalysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC operation, GMP compliance, QC testing, method validation, USP/EP test methods, laboratory equipment operation, data analysis, raw material sampling
Preferred skills
FTIR, Endotoxin testing, Dissolution testing, Karl Fisher, Conductivity, Osmometer, liquid sampler, Disintegration, Visible inspection, Appearance inspection, pharmaceutical formulation testing
Technologies
HPLC, FTIR, Osmometer, liquid sampler
Responsibilities
Execute laboratory HPLC methods following GMP and GDP standards; perform routine tests including FTIR, Endotoxin, Dissolution, Karl Fisher, Conductivity, Osmometer, liquid sampler, Disintegration, Visible inspection, and Appearance; participate in method development, validation, and qualification of compendial methods; assist in developing pharmaceutical formulations by testing excipients and vehicles; perform USP and EP test methods; inspect, release, and destroy production materials and chemicals; sample raw materials in an ISO Classified environment; operate and maintain laboratory equipment, perform calibrations, and troubleshoot; support quality control by reviewing and verifying test results and procedures.
Seniority
Mid-level, hands-on IC
