Laboratory Analysis entails conducting a wide range of laboratory analyses, often within a pharmaceutical manufacturing or clinical research setting, ensuring accuracy and compliance with regulatory standards.
Key responsibilities include:
* Performing routine and specialized tests such as clinical chemistry, hematological, coagulation, and immunological assays according to Standard Operating Procedures (SOPs)
* Maintaining the laboratory environment, ensuring safety specifications, and overseeing the maintenance and calibration of laboratory equipment required for clinical trials
* Quality assurance by performing quality control checks, investigating and documenting complaints and deviations, and conducting trend analyses
* Depending on the specific assignment, duties may extend to analytical method validation, preparing validation studies, managing and processing samples, and handling inventory of reagents and consumables
* GMP-compliant administrative tasks and ensuring laboratory Key Performance Indicators (KPIs) are met
Qualifications:
* Bachelor in a scientific field
* Possess strong analytical skills, attention to detail, and a results-oriented approach
* Ability to strictly follow written and oral instructions, safety procedures, and GMP standards
* Proficiency in laboratory information management systems (LIMS/gLIMS/PIMS) and other PC software applications like MS Office is crucial
* Strong problem-solving abilities, capable of investigating root causes and developing solutions for issues and deviations
* Excellent interpersonal and communication skills are vital for effective collaboration with internal teams and external stakeholders
* Prior experience as a lab analyst in the chemical or medical sector, or in Quality Control, is beneficial
* Flexibility in scheduling, potentially including covering inadvertent times for subject visits, may be required