Associate Scientist I, Immunoassay

• Effectively assist in the execution of routine sample analysis studies with oversight
• Ensure lab area is clean and inspection ready at all times
• Record tasks in accordance with Good Documentation Practices (GDP)
• Learn how to review and evaluate data results
• Perform data analysis in appropriate software for at least one analytical platform with oversight
• Perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
• Develop knowledge of regulatory requirements (GLP, GCP, GMP, EPA, OECD, CLIA, 21CFR Part 11) and apply as required by operational area
• Develops effective communication skills through both informal and formal discussions with peers, supervisor, internal teams, and externally with Regulators
• Accurately prepare reagent with oversight
• Accurately perform laboratory support functions such as labeling, monitoring expiration dates, waste removal and solution preparation with oversight
• Operate and maintain analytical instruments with minimal oversight as required by operational area
• Accurately write both study and non-study deviations with oversight
• Develop critical thinking, troubleshooting and time management skills aligned with the needs of the operational area

· BA/BS or higher; all experiences will be evaluated

· Able to perform basic lab work

· Able to work in a regulated environment

· Able to work effectively and contribute within a team

· Able to work with computer systems; able to document clearly