Investigator II

• Performs analyses and evaluations on import history and data samples and documented information gathered during inspections and investigations to ensure that documentation and practices follow Federal laws rules and regulations.
• Documents and organizes required evidence data and other information to support violations noted during inspections investigations sample collections field and label examinations or entry filer audits.
• Prepares final reports affidavits and other written documentation that support investigative findings and recommendations.
• Performs routine audits of entry filers (those firms submitting information when presenting FDA regulated products for entry into the U.S.) to assure proper data submission to FDA.
• Testifies as an expert witness in administrative hearings and judicial proceedings.
• Conducts inspections and investigations to follow up with non-compliant industry establishments on previously noted violations.

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises you must take affirmative steps to resolve the matter.
• Males born after December 31 1959 must be registered with the Selective Service. Please go to for more information.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired you may be subject to additional investigations at a later time.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration non-selection or appropriate legal action.
• Probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.
• This position requires the incumbent to have the following current license and/or certification: Must possess a valid drivers license to drive a government or privately owned motor vehicle.
• Candidates for this position must complete a statement regarding their physical ability and may be required to undergo physical examination.
• Position may include shift work and/or weekend work.
• May be required to work long and unscheduled hours.
• May be exposed to all kinds and extremes of weather and noise.

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 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. FDAs 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:

• Bachelors 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-
• Masters 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.