Quality Control Analyst I
Core
Characterization of biological materials and providing support to manufacturing with timely and accurate in-process and final product testing.
Role type
Quality Control Analyst I
Builds
Diagnostic quality solutions and component materials for the life sciences industry
Domain
Life Sciences / In Vitro Diagnostics (IVD)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ELISA testing, immunoassays, bioburden testing, Western Blot, endotoxin testing, sterility testing, clean room environmental monitoring, water system sampling, equipment calibration, preventative maintenance, data analysis, control charts, trend analysis, cGMP compliance, ISO standards compliance
Preferred skills
Automated chemistry analyzers, immunoanalyzers, regulated laboratory setting
Technologies
ELISA, immunoassays, Western Blot, endotoxin testing, sterility testing
Responsibilities
Perform routine testing on raw material samples and finished biological products, analyze and record testing data, perform clean room environmental monitoring and water system sampling, maintain equipment calibration and preventative maintenance, maintain electronic databases of sample submission and testing, produce and use control charts, perform tracking and trend analysis on laboratory data, document technical problems and report to Supervisor, enter test results into electronic database, scan and file paper records, adhere to Standard Operating Procedures and regulatory requirements, assist with implementation of corrective actions in response to audits, maintain appearance of QC lab for audit readiness
Seniority
Entry-level, hands-on IC