22 Oct
|
Vitalbio
|
Oakville
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 rapid-paced, inter-disciplinary environment, and are excited to contribute to the development of high-quality diagnostic products.
What you'll do
- 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.
What you'll need
- 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 has departed from protocol, and perform first-pass review of study data.
- Phlebotomy certification or documented equivalent, current, with willingness to perform venipuncture and capillary collections.
- Experience with biobanking and managing inventory of clinical samples, including serum, plasma and whole blood: intake, aliquoting, storage conditions, tracking and disposition.
- Experience contriving samples for sensitivity, linearity and method comparison studies, including spiking, admixture and dilution schemes.
- Experience working with SOPs in a regulated environment, with disciplined documentation habits.
- Proficiency with Microsoft Office or Google Workspace; familiarity with an eQMS
📌 Clinical Laboratory Technician (Oakville)
🏢 Vitalbio
📍 Oakville