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 B (GS-12 equivalent).
In order to qualify for the Senior Investigator I position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/14/2025: 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 three 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 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- 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 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- Five 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.
Inspections and Investigations Incumbent performs various activities including domestic sample collections, establishment inspections, unusual or novel special investigations, remote regulatory assessments (RRAs), recall audit checks, and emergency activities of moderate difficulty within the incumbent's assigned area of responsibility. When precedents, inspection programs, and guidelines are outdated, too broad, or in other ways inadequate, the incumbent assists higher-level employees with determining approaches that are influenced by precedents drawn from ongoing improvements in program concepts, advancements in the sciences and industry, or specialized program concepts, determining accepted or recognized standards, or providing expertise in scientific regulatory programs. Assists the immediate supervisor or a team leader by planning inspections, investigations, sample collections, and related activities in the area of assigned responsibility, trains new personnel and provides training for personnel, trains State and local government personnel and when required, conducts international inspections. Independently plans and conducts regulatory inspections and in-depth investigations of various industry establishments, such as manufacturers, specification developers, contract manufacturers, sterilizers, initial importers, and distributers. Assignments are frequently complicated by a variety of diverse products, highly specialized and sophisticated processes and equipment, products that are misbranded or adulterated or unapproved, complex quality control systems, or uncooperative establishment management. Incumbent conducts re-inspections to follow up with non-compliant industry establishments on previously noted violations. The Investigator conducts inspections and investigations (domestic and/international) of facilities where only limited guidance documents are available; proposed or new regulations must be used to evaluate the industry or the inspection or investigation may result n considerable attention and review in the media, Congress, or other forces inside or outside the Agency. The Investigator conducts more complex, technical investigations and inspections of establishments in the area of assigned responsibility. The Investigator may be assigned to long-term investigations and grand juries with only limited oversight from the supervisor; may be designated as the lead Agency representative of multi-agency/multi-organization investigations, and is assigned to assist or directly monitor or manage compliance programs for sample collection programs or inspection programs. Performs investigations involving complaints of illness, injury, or death attributable to products regulated by the FDA. Investigations require special coordination and a high degree of insight and knowledge. Expert judgment must be used to make field decisions on the nature and extent of follow-up investigations. Plans and decides how the investigation should proceed, when the investigation is complete, and what reporting is required. Provides timely and accurate feedback to Program and Headquarters management as well as effective guidance to other Program staff assisting in the investigation. The Investigator may serve as a coordinator and/or head investigator in the conduct of complex assignments requiring one or more investigators, analysts, or outside experts, and/or personnel from other Federal agencies, State, local, or foreign governments. Testifies as an expert witness in administrative hearings and judicial proceedings. Analysis and Reporting Incumbent performs analyses and evaluation on potentially complex data samples and documented information gathered during inspections and investigations, utilizing novel approaches as needed to ensure compliance with Federal laws, rules, and regulations. Documents and organizes required evidence, data, and other information to support violations noted during inspections, RRAs, investigations and sample collections. Interacts with and advises various levels of officials representing the establishments subject to regulatory review. Initiates contact with industry officials and manufacturers to obtain basic, incomplete, or missing information on regulatory and scientific documents, to discuss the status of investigations, and to attend meetings and conference calls. Prepares final Establishment Inspection Report (EIR), investigations memoranda, and proposed or final endorsements for inspections and investigations conducted. Reports are developed and, in most instances, accepted with little review of format or content. Incumbent interacts with and advises various levels of management officials representing the regulated industry, associations, state, local and foreign governments including those which may be contentious and require special skills to moderate conversations.