PRIMARY RESPONSIBILITIES
Ensure samples are processed and analyzed according to established methods and procedures in support of quality and management systems.
SPECIFIC RESPONSIBILITIES
- Use sophisticated laboratory instrumentation and computer systems to collect and record data.
- Update and calibrate lab analysis instrumentation.
- Perform intermediate checks for laboratory equipment and instruments.
- Perform trouble shooting and preventative maintenance on laboratory equipment and instruments.
- Handle data entry, update records, develop reports, SOPs, quality control, etc.
- Write standard operating procedures for analytical methods.
- Train other analysts on new analytical methods.
- Assist in the development, validation and implementation of new analytical methods.
- Maintain accurate and up-to-date records of all analyses.
- Deliver consistent and precise results following safety protocols and SOPs.
- Identify and follow-up on any deviations in results outside of normal limits.
- Review and update SOPs.
- Ensure regulatory compliance working with the QMS.
- Develop/maintain SOPs and work instructions.
- Verify the quality of the test results by using pre-defined performance criteria, QC charts.
- Schedule maintenance service on instruments.
- Investigate problems and make decisions, after consultation with the Directors, in all aspects of laboratory management
- Keep abreast with developments in the field.
- Identify and follow-up with the appropriate person regarding any departures from the management system or from the procedures for performing tests
- Analysis using LCMS.
- Method Validation
Method modification and development and validation of new methods
- Perform analysis and report results required for method and instrument validation.
- Report shortcomings and deviations and perform communicated actions to implement and improve new and existing methods and procedures.
Quality system
- Perform Health and Safety inspections in designated areas.
- Report deviations and communicate instructions to improve and maintain the quality system.
- Record keeping of all control and reference sample results.
Quality System
- Authorized to investigate and process nonconforming issues and implement corrective and preventive actions.
- Authorized to investigate and process improvement request issues and implement corrective and preventive actions.
- Responsible for control over monitoring, maintaining and housekeeping of accommodation and environment.
- Responsible for all reference materials and standards required for measurement of traceability.
- Quality assurance of analytical results
- Authorized and responsible for control and interpretation of control charts
Specific Authorities
- Cease the use of any equipment that may be deemed to constitute a safety hazard or entry to hazardous environments without the necessary knowledge and protection, and take action to address the hazard.
- Cease to carry on with work that may affect the quality (integrity) of services and take action to address the issue.
- Initiate a formal improvement request when a deviation of the system occurs, possible improvements are identified or when nonconformity is identified.