Associate Investigator

FDA; Newark (NJ); On-site; USD 54,000 - 70,000; Full time

Job summary

FDA in Newark, NJ seeks an Associate Investigator to conduct inspections of FDA-regulated industries and document violations. The role supports safety and quality by evaluating compliance with U.S. laws and regulations, preparing reports with evidence, and mentoring junior staff.

A strong background in QA/Regulatory fields is expected, with transcripts required for education verification. Join a critical public health team within DHHS, contributing to consumer protection and the integrity of the

Qualifications

• Bachelor's degree or higher in quality assurance/management, data science, statistics, epidemiology, public health, or related field with accredited program.
• Band W requires a bachelor’s degree with no experience, or at least 2 years of comparable FDA-regulated industry experience.
• Transcript(s) must be submitted to demonstrate required education.
• Experience in FDA-regulated environments or investigations is preferred.

Responsibilities

• Inspect FDA-regulated industries and collect information to document violations of the FD&C Act and related laws.
• Prepare and submit reports with supporting evidence documenting violations.
• Evaluate compliance with U.S. laws and regulations to promote safety and quality.
• Mentor less experienced personnel and provide stakeholder outreach as needed.

Skills

Critical thinking

Data analysis

Investigations

Regulatory compliance

Education

Bachelor's degree in quality assurance/management or related field

Tools

Computer applications

Job description

Summary

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 W (GS-7 equivalent).

Duties

Summary

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 W (GS-7 equivalent).

Requirements

Qualifications

In order to qualify for the Associate Investigator 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 the following: Education: A bachelor'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.To qualify for Band W candidate must have: A bachelor's degree or higher with no experience. OR Experience: To qualify for Band W without a bachelor's degree, the candidate must have at least 2 years of comparable experience.Comparable experience is defined as experience with FDA, a state or federal partner agency, or in an FDA-regulated industry or organization providing investigative or compliance services to an FDA-regulated industry, focused on evaluating or ensuring compliance with FDA or related public health laws and regulations. Desired Experience: Band W: Our ideal candidate will have experience in the following: Applying critical thinking as it pertains to a range of professional theories, concepts, principles, and methods to determine, execute, and explain actions standard practices, equipment, devices, processes, and well-known techniques and resolve a wide variety of complications and constraints contained in traditional projects. Utilizing computer applications to accomplish projects, designs, plans, and reports; to perform and interpret analyses and computations for unknown factors; and to define relationships in factual matters involving well-understood issues. Conducting and performing investigations using the scientific method including performance monitoring and quality assurance principles and conducting research by applying accepted and relevant business, and organizational practices. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

Become a part of the Department that touches the lives of every American. At the Department of Health and Human Services (HHS) you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans. The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Inspections and Investigations (OII), Office of Import Operations (OIO). The Office of Inspections and Investigations (OII) is at the forefront of building a public health safety net for today's complex, global regulatory environment. OII professionals work in a range of program areas and locations, with 196 offices throughout the United States.