The Research Associate II is a laboratory-oriented position that is primarily focused on the generation of dependable laboratory data, however, also has the capability to contribute to experimental design and independently execute and analyze studies with minimal guidance from more senior staff. This position will be expected to contribute to written protocols and data summaries used in study reports, validations, and Design Control related documents.
- Understand, implement, and contribute to experimental designs relating to new products or product improvement projects
- Projects may include new or improved quality controls, calibrators, proficiency materials, reagent, and assay systems for the clinical diagnostic/medical device industry.
- Independently execute experiments, gather, and analyze data and prepare written summaries and reports.
- Assist in discovery, research, development, product transfer and validation activities for new products and product improvement projects with minimal guidance from more senior staff
- Assist with providing documentation, data analysis, summaries, reports in accordance with the Design Control procedure per FDA, ISO and IVD Directive standards
- Maintain laboratory notebooks and assists with the preparation of the Design History Files for each project.
- Present research work within the R&D group
REQUIREMENT FOR THE POSITION:
- Minimum M.S. in biochemistry, chemistry, clinical chemistry or similar with 2 years of relevant experience or B.S. with 5 years of relevant experience (working in a clinical or medical device/IVD laboratory or an FDA regulated quality assurance medical device or pharmaceutical manufacturing environment
- Ability to design and conduct experiments with minimal supervision
- Ability to analyze and present data in a coherent and scientifically valid manner
- Knowledge of assay troubleshooting and development
- Basic use of Excel spreadsheet and statistics