Job Purpose:
Under direct supervision, uses fundamental concepts, practices, and procedures, together with particular platforms, to perform routine clinical sample processing. These tasks may require the application of established techniques, procedures, and criteria. This includes the generation of revenue by conducting fee-for-service analyses of biological samples (e.g., blood, saliva, stool, urine, bacteria, etc.) for external clients using various equipment (e.g., flow cytometers, centrifuges, incubators, analytical and statistical software, office equipment, etc.).
Candidate must have flow cytometry experience.
Main areas of responsibility:
- Develops and validates bioanalytical tests under the guidance of Scientists.
- Performs clinical sample analysis and clinical sample reporting.
- Ensures clear audit trails by performing quality control of all information and data generated.
- Assists with documents for projects (e.g., Lab Manuals, Validation Phase Plans, Method Development Plans, Sample Analysis Plans, Sample Analysis Reports, etc.).
- Assists with multiple projects in a fast-paced laboratory environment.
- Management, monitoring, and ordering of consumable stock to ensure sufficient reagents are available for assays.
- Conducts stock takes, including stock management on a Laboratory Information Management System (LIMS).
- Maintains strong adherence to regulatory compliance and safety requirements involving GCLP, SOPs, Health & Safety policies, and related documents.
- Assumes responsibility as Study lead on projects and chief analyst on assay methods.
- Uses Odoo timesheet and planning tools accurately and efficiently.
Ad-hoc tasks:
- Writes and/or reviews/validates SOPs, SWPs, documents, forms, and spreadsheets.
- Documents and updates installation, operation, and performance qualifications (IQ/OQ/PQ) of equipment, including new equipment, preventive maintenance, and services.
- Ensures equipment used for assays is fit for purpose and within service dates (equipment custodian).
- Performs setup, start-up, and verification of analysers (e.g., electrochemiluminescence analysers, microplate readers, flow cytometers) and laboratory equipment (e.g., centrifuges, pipettes, timers, thermometers).
- Performs daily housekeeping duties.
- Completes and maintains documentation related to clinical trials, such as overview documents, sample logistics tracking forms, worksheets, and method sheets.
- Ensures correct, timely, and documented receipt of samples and reagents, including proper storage and retrieval.
- Assists with training staff in procedures and validated methods.
Skills and Competencies required:
- General understanding of bioanalytical & biomarker services to support operations.
- Excellent interpersonal skills.
- Ability to motivate and drive internal stakeholders.
- Effective task prioritization and time management.
- Attention to detail and ability to work under pressure.