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. They will assist with filling out all the paperwork associated with new LDTs submissions tothe appropriate parties.

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 construct assay specific test menus, source materials required to complete validation, able to troubleshoot issues occurring with extraction and PCR procedures before performing validation studies

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

Ability to manually pipet using a single channel and multi-channel pipet

Able to perform calculations for dilutions and reagent preparation

Education

Bachelor?s Degree in Chemistry, Toxicology, Biology or a related science

Experience

2 years pertinent laboratory experience in a research and development setting

Skills

• Meticulous attention to detail

• Good oral communication

• Able to read and interpret information

• Listens and gets clarification

• Able to read information quickly and retain it for use in processing

• Edits work for spelling

• Strong technology skills

• Working knowledge of Microsoft Word, Excel and Outlook

• Ability to learn

• Able to work in a team-oriented environment

Physical Requirements

• Standing or sitting for an extended period of time

• Able to lift 25 lbs.

• Repetitive wrist motion

• Audible recognition of alarms

• Ability to discriminate colors is essential

Time

Shifts extend until work is finished
Occasional weekends