Investigator I

U.S.-Food-and-Drug-Administratio; Anchorage (AK); On-site; USD 72,000 - 90,000; Full time

Job summary

The U.S. Food and Drug Administration in Anchorage seeks an Investigator I under Title 21 authority (GS-9 equivalent) to inspect FDA-regulated industries worldwide and assess compliance with U.S. laws.

Candidates must have a Bachelor's degree in QA/Management or related field, or a Master's, or 3 years of experience; transcripts required. This role emphasizes safety and quality to prevent unsafe products from reaching patients and the public.

Qualifications

• Bachelor's degree in QA/management, data science, statistics, computer forensics, epidemiology, pharmacy, public health, engineering, food science, law or regulations, or related field from an accredited institution AND one year of experience; OR
• Master's degree or higher in one of the listed fields from an accredited institution; OR
• Without a related degree, at least three years of comparable experience.

Responsibilities

• Conduct inspections of FDA-regulated establishments worldwide.
• Gather evidence and prepare reports documenting violations of the FD&C Act and related laws.
• Assess compliance with U.S. laws and regulations to promote safety and quality.
• mentor less experienced personnel and provide stakeholder outreach and education.

Skills

Inspections

Regulatory knowledge

Reporting

Critical thinking

Education

Bachelor's degree in QA/Management or related field

Master's degree in QA/Management or related field

3 years of comparable experience

Job description

This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band Y (GS-9 equivalent). In order to qualify for the Investigator I position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 10/01/2026:

Basic Qualification Requirements:

This Investigator job family covers professional positions that conduct inspections in FDA regulated industries and prepare and submit reports accompanied by supporting evidence documenting violations of the FD&C Act and other laws, regulations, and requirements administered by FDA. The position investigates and/or inspects FDA-regulated industry globally and evaluates compliance with U.S. laws and regulations in order to promote a culture of safety and quality with the objective of preventing unsafe, ineffective and/or defective products from becoming available to patients and consumers or used in clinical trials while facilitating appropriate development of novel products. FDA's enforcement of the laws and regulations protects patients and consumers from products that are impure, unsafe, ineffective, improperly or deceptively labeled or packaged, or in some other way dangerous or defective. Investigators routinely examine products; collect samples; conduct inspections of establishments that design, make, process, hold, or distribute FDA-regulated products; and otherwise gather information and evidence to document objectionable conditions and assess compliance with U.S. law and regulations. Investigators apply critical thinking to evaluate manufacturing processes, design practices, facility and material controls, supply chains, quality management systems, laboratory analyses, and clinical investigation programs to assess compliance with U.S. laws and regulations and to support advancements and innovations. Investigators continuously maintain required certification and credentials; provide internal and external stakeholder outreach, assistance, and education; and may mentor less experienced personnel. These positions require knowledge of various scientific fields such as biochemistry, biology, biotechnology, chemistry, data science, digital health, engineering, epidemiology, food engineering, food processing technologies, food safety, healthcare, medical technology, microbiology, nutrition, pharmaceutical science, pharmacology, public health, quality assurance, and quality management.

Education/Experience Requirement:

Candidates must meet one of the following:

• 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. The degree must be from an accredited program or institution; AND one (1) year of comparable experience; -OR-
• 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. The degree must be from an accredited program or institution; -OR-
• Without a related degree, candidate must have at least three (3) years of comparable experience.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.