Associate Investigator

Associate Investigator

Company: Food and Drug Administration

Location: Multiple

Job Responsibilities:

  • 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.

Qualifications:

Conditions of employment

  • 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 http://www.sss.gov 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 driver’s license to drive a government or privately owned motor vehicle.
  • May be required to undergo physical examination.
  • Position may include shift work and/or weekend work.
  • May be exposed to all kinds and extremes of weather and noise.

Qualifications

In order to qualify for the Associate Investigator 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. 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 the following:

Education: A bachelor'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.To qualify for Band W candidate must have: A bachelor's degree or higher with no experience.

OR

Experience: To qualify for Band W without a bachelor's degree, the candidate must have at least 2 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.

Desired Experience: Band W: Our ideal candidate will have experience in the following:

  • Applying critical thinking as it pertains to a range of professional theories, concepts, principles, and methods to determine, execute, and explain actions standard practices, equipment, devices, processes, and well-known techniques and resolve a wide variety of complications and constraints contained in traditional projects.
  • Utilizing computer applications to accomplish projects, designs, plans, and reports; to perform and interpret analyses and computations for unknown factors; and to define relationships in factual matters involving well-understood issues.
  • Conducting and performing investigations using the scientific method including performance monitoring and quality assurance principles and conducting research by applying accepted and relevant business, and organizational practices.


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

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