About the role

The ideal candidate will be responsible performing lab activities in accordance with applicable Methods, Plans, SOPs/SWPs, GLP regulatory guidelines and 21 CFR Part 11 as directed from Group Leader and Sr. Analysts. Independently conduct Bio-analysis validation and sample analysis in support of nonclinical and clinical studies. Conduct Pre-Study with minimal supervision. Utilize establish techniques to compile and analyze data. Document work and maintain study documentation and lab records.
Responsibilities: Understand and comply with GLP requirements and follow Methods, Plans and SOP/SWPs and related lab procedures; comply with safety policies, comply with company policies. Use and properly maintain lab instrument and equipment appropriately for assigned tasks. Conduct Bio-analysis validation and sample analysis independently meeting company quality standards. Conduct pre-study method development with minimal supervision. Prepare worksheets. Data processing and table preparation (i.e., QC data and preparation, data integration, raw data printing, preparation of chromatograms for the report, use of Watson LIMS, etc.)Maintain accurate records of work and study documentation per Good Documentation Practices as per company SOPs.
Qualifications: Bachelor's degree or equivalent experienceELISA – absorbance, fluorescence, luminescence

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