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.
Inspections and Investigations The incumbent independently conducts complex inspections and investigations (domestic and international) and sampling at human food facilities covering all types of products and problems within the area of assigned responsibility. Investigates and evaluates the adequacy of complex manufacturing practices to determine compliance with Current Good Manufacturing Practices (cGMPs), Preventive Controls and other human food regulations. Incumbent interacts with and advises various levels of officials representing the establishments subject to regulatory review. The incumbent initiates contact with industry officials to obtain information on regulatory and scientific documents and to discuss the status of investigations. Incumbent conducts re-inspections to follow up with non-compliant industry establishments on previously noted violations. In situations where compliance is not offered, it is enforced through other methods, including administrative action, informational agency meetings, and legal court actions. Assists the immediate supervisor in planning inspections, investigations, sample collections, and related activities in the area of assigned responsibility; trains new personnel, monitors or manages sample collection or inspection programs, as appropriate. Performs investigations involving complaints and trace-back investigations of illness, injury, or death attributable to products regulated by the FDA. Investigations require special coordination and a high degree of insight and knowledge. The information which initiates such investigations is often minimal, unclear and the veracity unknown requiring innovation, ingenuity, and diplomacy. These situations are often unstructured and require contacts with many and diverse individuals, institutions, and firms. Mature 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. Analyzes results, decides when an inspection/investigation is complete or what additional work may be required. Incumbent interacts with and advises various levels of officials representing the regulated industry, associations, state, local and foreign governments including those which may be contentious and require special skills to moderate conversations. Provides timely and accurate feedback to inspectorate and headquarters management as well as effective guidance to other inspectorate staff assisting in inspections/investigations. Assists all Human Food Divisions in the completion of OII's workplan and other human food priorities (e.g., on the job experience, coaching). Performs other duties as assigned. Analysis and Reporting The incumbent performs analyses and evaluation of 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, investigations, and sample collections. May serve as an instructor providing investigation and inspection training to lower grade trainees. Assist in training state and local government officials to ensure compliance with federal laws. May testify as an expert witness in administrative hearings and judicial proceedings. Prepares final report, investigations memoranda, and proposed or final endorsements for inspections and investigations. Reports are developed and, in most instances, accepted with little review of format or content and in accordance with quality elements. Advises on potentially controversial inspections and investigations that require additional monitoring or legal action. May provide training to other investigators or state and local agencies in inspection and investigation techniques. Assist in designs of agendas for and participates in training programs for inspectorate area and industry personnel. May be assigned as a mentor of lower graded personnel to ensure they receive the correct mix of formal and on-the-job training. The incumbent may serve as a team leader or coordinator in the conduct of complex assignments requiring one or more investigators, analysts, outside experts, and/or personnel from other federal agencies, state, local, or foreign governments.