Jobs · Information Technology · Ohio

Investigator I

FDA · Cincinnati, OH · 1 mo ago
Information TechnologyFull-time
We need to output HTML fragment with sections: headings

for sections present. The posting includes Duties Summary (but we should not repeat job title). The content includes duties summary paragraph, then Requirements Qualifications (actually heading "Requirements Qualifications"? The text shows "Requirements Qualifications" as a heading? Actually it's "Requirements Qualifications" line then paragraphs. We'll treat as a section heading "Requirements". Also there is "Education/Experience Requirement:" inside that. Also there is a paragraph about "Become a part of the Department..." etc. That's more like "About the role" or "Overview". Also location info. We need sections: maybe "About the role", "Responsibilities", "Requirements", "Qualifications", "Skills", "Benefits", "Pay", "Schedule". We only include sections with real specific content. We have duties summary: that's responsibilities. So we can have

Responsibilities

with

containing the duties summary paragraph(s). Also there is a paragraph about "Become a part of the Department..." maybe "About the role". Also location info maybe part of About. We have requirements/qualifications: the block after "Requirements Qualifications". So we can have

Requirements

with

containing the description of Investigator job family, etc. Then maybe

Qualifications

with education/experience requirement list. Could also combine but better separate. We have no explicit Pay, Schedule, Benefits. So we omit those. We need to use
  • for any list of duties/requirements/benefits. The duties summary is prose, not list. The requirements block includes bullet-like sentences? Not explicit list. The education/experience requirement is a list of options: could be formatted as
    • . We'll do that. We must preserve all substantive information, not invent. We must remove boilerplate: cookie/navigation/legal/EEO etc. Not present. We must not repeat job title as heading. Not include Job ID. We must not create sections with filler like "commensurate with experience". Not present. Let's extract content. Original text: "Duties 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)." That's duties summary? Actually it's more about hiring authority. Then later: "Requirements 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 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 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. Become a part of the Department that touches the lives of every American. At the Department of Health and Human Services (HHS) you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans. The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Inspections and Investigations (OII), Office of Import Operations (OIO). The Office of Inspections and Investigations (OII) is at the forefront of building a public health safety net for today's complex, global regulatory environment. OII professionals work in a range of program areas and locations, with 196 offices throughout the United States." We need to split into sections. Potential sections: - Responsibilities: The duties summary paragraph (first paragraph) maybe also includes the description of what investigators do (the long paragraph after Basic Qualification Requirements). Actually that paragraph describes the role/responsibilities. So we could put that under Responsibilities. - Requirements: The block about "Basic Qualification Requirements:" maybe includes description of job family. Could be considered Requirements. - Qualifications: The Education/Experience Requirement list. - About the role / Overview: The motivational paragraph about HHS, FDA, location, OII. We must not duplicate content. Let's decide: Responsibilities: Use the paragraph that starts "This Investigator job family covers professional positions that conduct inspections..." through "...and may mentor less experienced personnel." That's a description of duties. Requirements: Could be the "Basic Qualification Requirements:" heading? Actually that heading is part of the qualifications block. But we already used that paragraph for responsibilities. Might be better to treat the "Basic Qualification Requirements:" as part of Requirements (description of what the job entails). However the instruction: "Use

      for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So we can have both Requirements and Qualifications sections. Thus: - Responsibilities: the duties description (the long paragraph about investigators' tasks). - Requirements: maybe the "Basic Qualification Requirements:" paragraph that describes the Investigator job family? Actually that's same as responsibilities. Hmm. Let's parse: The text after "Basic Qualification Requirements:" is a description of the Investigator job family. That seems like a description of what the job entails (responsibilities). Then after that, there is "Education/Experience Requirement:" which is qualifications. Thus we can assign: Responsibilities: the paragraph after "Basic Qualification Requirements:" up to before "Education/Experience Requirement:". Qualifications: the Education/Experience Requirement block. Requirements: maybe we can include the initial "Duties Summary" paragraph about hiring authority and pay band? That seems like requirements? Actually it's about appointment type and pay table. Could be considered Requirements (eligibility). But we already have Qualifications for education/experience. The hiring authority and pay band could be considered "Requirements" (like eligibility). However the instruction says not to create sections with filler like "commensurate with experience". This is specific info about appointment type and pay band. Could be placed under Requirements. Alternatively, we could combine the hiring authority paragraph into a short

      under Requirements. Let's decide: Section Responsibilities: the investigator duties paragraph. Section Qualifications: the education/experience options as a list. Section About the role: the motivational paragraph about HHS, FDA, location, OII. We might also include a short paragraph under Requirements about the hiring authority and pay band. But we already have Qualifications; maybe we can put that under Requirements as a brief note. Let's extract the hiring authority paragraph: "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)." That's specific. We'll put under Requirements as a

      . Now the Responsibilities paragraph: from "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." through "...and may mentor less experienced personnel." Let's copy that exactly. Now Qualifications: the Education/Experience Requirement block. We need to format as list. The block: "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

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