Investigator I: Regulatory Compliance & Inspections

FDA; Itasca (IL); On-site; USD 52,000 - 64,000; Full time

Job summary

FDA in Itasca, IL seeks an Investigator I under streamlined hiring authority (21 US Code 379d-3a). This GS-9 equivalent role requires a strong QA/health science background and offers a career or career-conditional appointment. A degree plus experience pathway applies as described in the job posting.

Responsibilities include inspecting FDA-regulated facilities, collecting samples, evaluating compliance with U.S. laws, and preparing evidence-backed reports.

Qualifications

• Bachelor's degree in a related healthcare or science field with one year of experience.
• Master's degree or higher in a related field may substitute for experience.
• Three years of comparable experience in FDA-regulated industry or related field.

Responsibilities

• Inspect FDA-regulated facilities and collect samples to assess compliance.
• Evaluate manufacturing processes, controls, and quality management systems.
• Prepare reports with supporting evidence documenting violations of laws and regulations.
• Mentor less experienced personnel and communicate findings to stakeholders.

Education

Bachelor's degree in quality assurance/management, data science, statistics, computer forensics, epidemiology, pharmacy, public health, engineering, food science, law or regulations, or related healthcare or science field

Master's degree or higher in quality assurance/management, data science, statistics, computer forensics, epidemiology, pharmacy, public health, engineering, food science, law or regulations, or related healthcare or science field

Three years of comparable experience in FDA-regulated industry or related field (without a related degree)

Job description

FDA in Itasca, IL seeks an Investigator I under streamlined hiring authority (21 US Code 379d-3a). This GS-9 equivalent role requires a strong QA/health science background and offers a career or career-conditional appointment. A degree plus experience pathway applies as described in the job posting.

Responsibilities include inspecting FDA-regulated facilities, collecting samples, evaluating compliance with U.S. laws, and preparing evidence-backed reports.