Associate Scientist I- Immunoassay

• Prepare reagents, standards, and control samples
• Analyze samples using various techniques specific to department
• Ensure lab area is clean and inspection ready at all times
• Remove lab waste
• Record tasks in accordance with Good Documentation Practices (GDP)
• Learn and apply regulatory requirements; GLP, GCP, 21CFR Part 11
• Follow applicable SOPs and procedural documents
• Learn how to review and evaluate data results

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

Ensure the laboratory area is clean and inspection ready at all times

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

Effectively assist in the execution of routine sample analysis studies with oversight

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

Perform data analysis in appropriate software for at least one analytical platform with oversight

• · 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

Associate Scientist I- Performs routine lab work and sample analysis under supervision