You are a meticulous bench scientist who takes ownership of analytical quality. You run clinical chemistry, immunoassay and hematology analyzers day to day, and you understand that a result is only as good as the calibration and quality control standing behind it. You are comfortable making a technical call — accepting or rejecting a QC event, holding a result that does not look right.
You're highly motivated, eager to learn, and comfortable working in a fast-paced, inter-disciplinary environment, and are excited to contribute to the development of high-quality diagnostic products.
Own the quality control program for the clinical laboratory: define control materials, levels, frequency and acceptance criteria per assay, and review all QC data.
Make acceptance or rejection decisions on QC events, investigate out-of-control results to root cause, document the investigation and determine whether results are affected.
Perform and document calibration across all analyzers on assay-specific schedules, and recalibrate against defined triggers including new lot, major service, QC failure and drift.
Run patient and study samples across the analyzer fleet — Roche cobas c303, Beckman AU480, Beckman Access 2, Sysmex XN-1000 and Immulite 2000 XPi — and perform review of results against QC status and analytical measuring range.
Release routine results to requesting teams and confirm receipt, escalating results that fall into defined exception categories to the Clinical Lead before release.
Execute method validation and verification studies to approved protocols: precision, linearity, method comparison.
Prepare samples, dilutions and admixtures to protocol specification, and perform first-pass technical review of study data covering run acceptability, QC status, instrument flags, outliers and protocol departures.
Escalate study deviations at the time they occur, and provide complete, traceable raw data and a record of study conditions for reporting.
Support installation, operational and performance qualification of newly installed analyzers.
Own the technical troubleshooting conversation with vendor customer care when first-line troubleshooting has not resolved a fault.
Direct QC execution by the clinical laboratory technicians, verify their runs meet procedure.
Contribute to development and revision of study protocols, work instructions and SOPs.
Author study reports summarizing methods, data, results, deviations, and conclusions against pre-defined acceptance criteria and CLSI method-evaluation protocols.
Provide backup phlebotomy and specimen processing, including capillary collections, when required.
Manage the clinical sample biobank: intake and accessioning, aliquoting, storage under defined conditions, inventory tracking and allocation across studies, and documented disposition of serum, plasma and whole blood samples.
Support the Assay Development team when required, including bench work, sample preparation and instrument time scheduled around clinical commitments.
Adhere to company code of conduct and laboratory safety practices.
Bachelor’s or master’s degree in life sciences, biochemistry, medical laboratory science, bioengineering or a related field; equivalent experience considered.
Two or more years of hands-on experience operating clinical chemistry, immunoassay or hematology analyzers in a laboratory setting.
Practical experience with quality control in a laboratory environment: running controls, interpreting QC data against acceptance criteria, and investigating out-of-control results.
Experience performing and documenting instrument calibration.
Working knowledge of CLSI method evaluation protocols sufficient to execute studies to a written design, recognize when a run…
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