Investigator I

Investigator I

Department: Department of Health and Human Services

Location(s): Lima, Peru, Aguada, Puerto Rico, Catano, San Juan, Puerto Rico, Mayaguez, Puerto Rico, Ponce, Puerto Rico, San Juan, Puerto Rico, Falls Church County, Virginia, Kalamazoo County, Michigan, Hudson County, New Jersey, Queens County, New York, Salt Lake City, Utah, Sandy, Utah, Highgate Springs, Vermont, Falls Church, Virginia, Ferrum, Virginia, Green Bay, Virginia, Montross, Virginia, Portsmouth, Virginia, Richmond, Virginia, Roanoke, Virginia, Scottsville, Virginia, Scottsville, Virginia, Sterling, Virginia, Warsaw, Virginia, Blaine, Washington, Bothell, Washington, Bothell, Washington, Leavenworth, Washington, Lynden, Washington, Oroville, Washington, Puyallup, Washington, Renton, Washington, Seattle, Washington, Seattle Heights, Washington, Spokane, Washington, Spokane Valley, Washington, Tacoma, Washington, Union, Washington, Morgantown, West Virginia, Green Bay, Wisconsin, La Crosse, Wisconsin, Madison, Wisconsin, Milwaukee, Wisconsin, Milwaukee, Wisconsin, Rhinelander, Wisconsin, Rio, Wisconsin, Rio Creek, Wisconsin, Wauwatosa, Wisconsin, Birmingham, Alabama, Birmingham, Alabama, Mobile, Alabama, Montgomery, Alabama, Anchorage, Alaska, Kotzebue, Alaska, Nogales, Arizona, Phoenix, Arizona, San Luis, Arizona, Sells, Arizona, Tempe, Arizona, Tuba City, Arizona, Whiteriver, Arizona, Little Rock, Arkansas, Alameda, California, Calexico, California, Carson, California, Chico, California, Daly City, California, El Segundo, California, Fairfield, California, Fresno, California, Irvine, California, Long Beach, California, Los Angeles, California, Martinez, California, Oakland, California, Ontario, California, Otay, California, Sacramento, California, Salinas, California, San Diego, California, San Francisco, California, San Jose, California, Signal Hill, California, South San Francisco, California, Stockton, California, Torrance, California, Arvada, Colorado, Arvada, Colorado, Colorado Springs, Colorado, Denver, Colorado, Lakewood, Colorado, Littleton, Colorado, Littleton, Colorado, Littleton, Colorado, Loveland, Colorado, Silverthorne, Colorado, Bridgeport, Connecticut, Hartford, Connecticut, Wilmington, Delaware, Washington, District of Columbia, Boca Raton, Florida, Fort Lauderdale, Florida, Fort Myers, Florida, Jacksonville, Florida, Longwood, Florida, Maitland, Florida, Miami, Florida, Miami Lakes, Florida, North Fort Myers, Florida, Orlando, Florida, Palm Coast, Florida, Ponte Vedra Beach, Florida, Sanford, Florida, Sumterville, Florida, Sweetwater, Florida, Tallahassee, Florida, Tampa, Florida, Viera, Florida, Windermere, Florida, Atlanta, Georgia, Atlanta, Georgia, College Park, Georgia, College Park, Georgia, Savannah, Georgia, Tifton, Georgia, Honolulu, Hawaii, Boise, Idaho, Eastport, Idaho, Bannockburn, Illinois, Bensenville, Illinois, Bensenville, Illinois, Chicago, Illinois, Chicago, Illinois, Gurnee, Illinois, Hinsdale, Illinois, Hinsdale, Illinois, Itasca, Illinois, Lisle, Illinois, Mount Vernon, Illinois, Peoria, Illinois, Springfield, Illinois, Indianapolis, Indiana, South Bend, Indiana, Davenport, Iowa, Decorah, Iowa, Des Moines, Iowa, Gypsum, Kansas, Lenexa, Kansas, Manhattan, Kansas, Overland Park, Kansas, Parker, Kansas, Wichita, Kansas, Frankfort, Kentucky, Independence, Kentucky, Lexington, Kentucky, Louisville, Kentucky, Baton Rouge, Louisiana, Covington, Louisiana, Lafayette, Louisiana, Metairie, Louisiana, Calais, Maine, Casco, Maine, Houlton, Maine, Portland, Maine, Baltimore, Maryland, College Park, Maryland, Dundalk, Maryland, Owings Mills, Maryland, Rockville, Maryland, Silver Spring, Maryland, Arlington, Massachusetts, Boylston, Massachusetts, Stoneham, Massachusetts, Worcester, Massachusetts, Detroit, Michigan, Dorr, Michigan, Fenton, Michigan, Grand Rapids, Michigan, Kalamazoo, Michigan, Lansing, Michigan, Lansing, Michigan, Lansing, Michigan, Port Huron, Michigan, International Falls, Minnesota, Miltona, Minnesota, Minneapolis, Minnesota, Jackson, Mississippi, Greenwood, Missouri, Kansas City, Missouri, Kansas City, Missouri, Kansas City, Missouri, Maplewood, Missouri, Saint Louis, Missouri, Springfield, Missouri, Bozeman, Montana, Crow Agency, Montana, East Helena, Montana, Helena, Montana, Sweet Grass, Montana, Omaha, Nebraska, Incline Village, Nevada, Las Vegas, Nevada, Concord, New Hampshire, Windham, New Hampshire, Bayonne, New Jersey, East Brunswick, New Jersey, Elizabeth, New Jersey, Jersey City, New Jersey, Marlton, New Jersey, Middlesex, New Jersey, New Brunswick, New Jersey, Newark, New Jersey, North Brunswick, New Jersey, Parsippany, New Jersey, South Bound Brook, New Jersey, Voorhees, New Jersey, Albuquerque, New Mexico, Dulce, New Mexico, Las Cruces, New Mexico, Shiprock, New Mexico, Zuni, New Mexico, Albany, New York, Alexandria Bay, New York, Binghamton, New York, Buffalo, New York, Central Islip, New York, Champlain, New York, Massena, New York, Bronx, New York, Kings, New York, New York, New York, Queens, New York, Richmond, New York, Ogdensburg, New York, Rochester, New York, Syracuse, New York, West Chazy, New York, White Plains, New York, Cary, North Carolina, Charlotte, North Carolina, Greensboro, North Carolina, Greenville, North Carolina, Raleigh, North Carolina, Wilmington, North Carolina, Fargo, North Dakota, Pembina, North Dakota, Brunswick, Ohio, Cincinnati, Ohio, Columbus, Ohio, Toledo, Ohio, Ardmore, Oklahoma, Clinton, Oklahoma, Lawton, Oklahoma, Oklahoma City, Oklahoma, Oklahoma City, Oklahoma, Oklahoma City, Oklahoma, Oklahoma City, Oklahoma, Oklahoma City, Oklahoma, Tulsa, Oklahoma, Tulsa, Oklahoma, Beaverton, Oregon, Hillsboro, Oregon, Portland, Oregon, Portland, Oregon, Portland, Oregon, Salem, Oregon, Salem, Oregon, Weston, Oregon, Glen Mills, Pennsylvania, Harrisburg, Pennsylvania, Philadelphia, Pennsylvania, Pittsburgh, Pennsylvania, Scranton, Pennsylvania, Shade Gap, Pennsylvania, Wilkes Barre, Pennsylvania, Wilkes Barre Township, Pennsylvania, East Providence, Rhode Island, Providence, Rhode Island, Charleston, South Carolina, Columbia, South Carolina, Columbia, South Carolina, Greenville, South Carolina, North Charleston, South Carolina, Pine Ridge, South Dakota, Sioux Falls, South Dakota, Chattanooga, Tennessee, Hermitage, Tennessee, Knoxville, Tennessee, Memphis, Tennessee, Nashville, Tennessee, Oakland, Tennessee, Austin, Texas, Austin, Texas, Brownsville, Texas, Castroville, Texas, Dallas, Texas, Dallas, Texas, Dallas, Texas, Dallas, Texas, Eagle Pass, Texas, El Paso, Texas, Fort Worth, Texas, Frisco, Texas, Galveston, Texas, Houston, Texas, Houston, Texas, Houston, Texas, Humble, Texas, Laredo, Texas, McKinney, Texas, Pharr, Texas, Rio Grande City, Texas, Sachse, Texas, Sachse, Texas, San Antonio, Texas, Dallas, Texas

Salary Range: $70623 - $93645 Per Year

Job 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 Y (GS-9 equivalent).

Major Duties:

• Inspections and Investigations Plans and conducts routine regulatory inspections and limited investigations of various industry establishments; such as manufacturers, re-packers, own label distributors, and importers. Independently carries out routine investigations, inspections, entry review, filer audits and sampling. Upon completion of assignment, prepares concise factual reports reflecting significant observations. Incumbent surveys and follows up with non-compliant industry establishments where violations are clearcut and seeks voluntary compliance. In situations where compliance is not offered it is enforced through other methods, including administrative action, informational agency meetings and legal court actions. Performs other duties as assigned. Analysis and Reporting Conducts analyses and evaluation on data samples and documented information gathered during inspections, RRAs, and investigations to ensure that documentation and practices comply 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. 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. Developmental assignments include assisting higher level employees in the review and evaluation of inspection reports of products or establishments submitted by the field for regulatory action consideration. Additional Developmental assignments include providing support (i.e., documenting conversations and noting circumstances) to higher level employees as they interact with industry officials on regulatory issues. Prepares final reports, memoranda, position papers and other written documentation that support investigative findings and recommendations. Reports are developed and, in most instances, accepted with little review of format or content. May be called to testify as an expert witness in administrative hearings and judicial proceedings.

Qualifications: 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 03/13/2026: 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. 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. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

How to Apply: In accordance with Executive Order 14170, applicants are encouraged to respond to the four short, free-response, essay questions in the questionnaire. Answers to these questions are optional and will not be scored or rated. Your answers will be reviewed by the hiring manager and agency leadership if you are referred for selection consideration. You will be asked to certify that your responses are written in your own words and that you did not use a consultant or artificial intelligence (AI) tool (such as ChatGPT or Copilot). Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution. To apply for positions with the Food & Drug Administration, you must have a https://secure.login.gov/ account, and be signed in to that account, before you click "Apply Online". See the USAJOBS Help Site article "How does the application process work?" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 03/13/2026. We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the close date. If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: https://help.usajobs.gov/how-to. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Contact us at: USAJOBS - Contact us FDA's Applicant Help Desk is not able to support USAJOBS-related issues. The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: https://appsupport-usastaffing.opm.gov/hc/en-us. This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you! You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis. If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 866-807-3742, or e-mail ERIC@fda.hhs.gov. The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 12902591 so that we may assist you faster.

Application Deadline: 2026-03-13