Research and Development Specialist, Monmouth Junction Job at Acutis Diagnostics Inc
Responsibilities
Personnel assigned to the Research and Development Division will perform method development and validations for new assays as well as periodic performance verification of current assay. This individual will assist with the roll out of new methods, QA activities, write SOPs, implement laboratory safety plans, training production staff as it relates to methods they have validated.
Specific Duties
- Reagent Preparation ? prepare stock solutions, QCs, and calibrators
- Instrument/Equipment Maintenance ? maintain resources according manufacturers? recommendations
- Develop and maintain competency in the operation of instrument and equipment as assigned and in laboratory-specific workflow practices
- Validation Planning Phase ? responsible for outlining a complete method validation plan that covers all components of the validation process
- Method Development ? perform literature reviews, construct an analyte library, assay optimizations
- Method Validation ? linearity, precision (intra and inter), accuracy, carryover, lower limit studies, interference, method comparison, dilution integrity, analyte stability
- Data Reduction ? Perform initial data reduction and data analysis using EP Evaluator and Microsoft Excel®, summarize experimental process, results and findings
- Validation of manual and automated sample preparation protocols
- Prepare SOPs
- Periodic verification of instrument performance; including calibration verification, carryover, instrument correlation and quality controls
- Safety equipment verification at prescribed intervals
- Assist in the investigation of incidents of nonconformity in the production environment
- Assist the laboratory during investigations of unusual patient results
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