Validation analyst/specialist (bioanalysis)
Location
Laval, QC | Canada
Job description
Our client, a global company providing biological, non-clinical, clinical and bioanalytical assay solutions to pharmaceutical and biotechnology companies, is currently seeking a Validation Analyst/Specialist.
Nature of position
Under the supervision of the Director of Operations, your main mandate will be to rigorously follow standard operating procedures (SOP) and good laboratory practices (GLP). As a manager, you will carry out various regulated analyzes of drugs and metabolites for production studies and for method validation by LC-MS/MS. In case of problem areas, you consult your immediate supervisor, propose appropriate action plans and make informed decisions to ensure efficient and compliant operations. As such you will see to:
- Perform the regulated analysis of drugs and metabolites in biological samples (extraction methods) for production studies and method validation by LC-MS/MS, in accordance with Good Laboratory Practices (GLP), regulations of the United States Food and Drug Administration (21 CFR Part 58), and principles of the OECD;
- Complete relevant forms related to sample analysis and document all steps performed;
- Analyze results by verifying chromatography and concentration data obtained;
- Assist the immediate supervisor in resolving analytical problems and generating data;
- Report any equipment or material issues to the immediate supervisor to ensure timely repair or replacement of equipment;
- Document all required information or deviations in a timely manner and in accordance with GLP and SOP (information sheet, deviation);
- Interact with R&D staff on ongoing validations and report any issues (system issues, extraction problems, etc.);
- Perform any other tasks related to the position.
Required qualification
- University degree or college diploma in biochemistry, chemistry, or any other relevant field;
- Minimum of 5 years of relevant experience in bioanalysis, including a minimum of 2 years of method validation;
- Knowledge of GLP regulations;
- Understanding of various extraction procedures (SPE, liquid-liquid, protein precipitation, derivatization);
- Relevant experience in bioanalysis (HPLC and mass spectrometry);
- Proficiency in both French and English, both orally and in writing;
- Ability to work independently and prioritize tasks;
- Ability to work efficiently to ensure projects are completed within the specified deadlines.
Salary and condition
Salary and conditions according to company policy and candidate experience.
Job tags
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