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 A (GS-11 equivalent).
In order to qualify for the Investigator II position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 06/13/2025: 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 and/or 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 two years of comparable 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; -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 AND one year of comparable 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; -OR- Doctorate 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- Four years of comparable 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. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
The Investigator II conducts inspections and investigations involving a combination of scientific and regulatory responsibilities which usually call for a number of atypical inspectional or intensive investigative approaches to be applied to a wide variety of regulatory functions or scientific evaluations. Conducts objective surveys and emergency activities within the assigned area of responsibility. Assists the immediate supervisor or a team leader by planning inspections, investigations, sample collections, and related activities in the area of assigned responsibility; training new personnel and providing training for high graded personnel. Independently plans and conducts regulatory inspections and in-depth investigations of various medical products establishments. Conducts re-inspections to follow up with non-compliant industry establishments on previously noted violations. Inspections and Investigations Assignments involve a combination of scientific and regulatory responsibilities of atypical inspections, or intensive investigative approaches using a variety of regulatory functions or scientific evaluations; and include the more difficult and complex sample collections, establishment inspections, unusual or novel special investigations. Performs analyses and evaluation on data samples and documented information gathered during inspections and investigations to ensure that documentation and practices are in compliance with Federal laws, rules and regulations. Documents and organizes required evidence, data, and other information to support violations noted during inspections, investigations, sample collections or filer audits. Gathers scientific and technical comments from team members, assists with the preparation of letters and correspondence relevant to the review, and contributes to status reports for submissions and investigations under review. Interacts with and advises various levels of officials representing the establishments subject to regulatory review. Initiates contact with industry officials to obtain basic incomplete or missing information on regulatory and scientific documents and to discuss the status of investigations. Prepares final reports, position papers and other written documentation that support investigative findings and recommendations. Prepares final Establishment Investigation Report (EIR), investigations memoranda, and proposed or final endorsements for inspections, investigations, and filer audits conducted. Supervisory responsibilities: This is a non-supervisory position.