Summary : This job is open to : The public :

- U.S. Citizens, Nationals or those who owe allegiance to the U.S.

Clarification from the agency : You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply.

Duties : Assignments involve a combination of scientific and regulatory responsibilities which usually call for a number of atypical inspections or intensive investigative approaches to be applied to a wide variety of regulatory functions or scientific evaluations.

- Complex sample collections, establishment inspections, unusual or novel special investigations. Incumbent 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.
- 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.
- When precedents, inspection programs and guidelines are outdated, too broad, or in other ways inadequate, the incumbent assists higher-level employees with determining approaches influenced by precedents drawn from ongoing improvements in inspectorate concepts, advancements in the sciences and industry, or specialized inspectorate 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.
- 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.
- Incumbent conducts re-inspections to follow up with non-compliant industry establishments on previously noted violations.
- 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 in considerable attention and review in the media, Congress, or other forces inside or outside the Agency.
- The Investigator may be assigned to long-term investigations and grand juries with only limited oversight from the supervisor.
- Provides timely and accurate feedback to inspectorate and Headquarters management as well as effective guidance to other inspectorate staff assisting in the investigation.
- Incumbent performs analyses and evaluation on potentially complex data samples and documented information gathered during inspections and investigations.
- Documents and organizes required evidence, data,



and other information to support violations noted during inspections, RRAs, investigations and sample collections.
- Prepares final Establishment Investigation Report (EIR), investigations memoranda, and proposed or final endorsements for inspections, investigations, and filer audits conducted.

Requirements : Conditions of employment :

- U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
- 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.
- Financial Disclosure may be required.
- Ethics Clearance may be required.
- 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.

Qualifications : 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 03/13/2026 :

- 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

📌 Investigator Ii (Lima)
🏢 US Food and Drug Administration
📍 Lima