Investigator II
FDA · Charleston, SC · 1 mo ago
Information TechnologyFull-time
We need to output HTML fragment with sections for duties, requirements, qualifications, etc. The posting includes Duties Summary (but not a heading). It includes Requirements Qualifications (maybe combine). There's no explicit Benefits, Pay, Schedule sections. So we should only include sections that have real content: Duties (maybe "Responsibilities"? The posting has Duties Summary). Use for section headings: e.g., About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to map content to appropriate headings. The posting includes "Duties Summary" which could be under Responsibilities. Also includes "Requirements Qualifications" which could be Requirements and Qualifications sections. There's also a description of the role, mission, etc. Could be About the role. There's no explicit Skills list, but there is a list of knowledge fields (biochemistry, biology, etc.) that could be under Skills or Requirements. We need to preserve all substantive info. We'll create sections: About the role (intro paragraph), Responsibilities (duties), Requirements (basic qualification requirements), Qualifications (education/experience), Skills (knowledge fields). No Benefits, Pay, Schedule.
We must not repeat job title as heading. No Job ID etc.
We must remove boilerplate like "Become a part of the Department..." maybe that's substantive? It's motivational but still part of posting. It's not boilerplate like EEO. We can keep as part of About the role.
We need to use
for section headings: e.g., About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to map content to appropriate headings. The posting includes "Duties Summary" which could be under Responsibilities. Also includes "Requirements Qualifications" which could be Requirements and Qualifications sections. There's also a description of the role, mission, etc. Could be About the role. There's no explicit Skills list, but there is a list of knowledge fields (biochemistry, biology, etc.) that could be under Skills or Requirements. We need to preserve all substantive info. We'll create sections: About the role (intro paragraph), Responsibilities (duties), Requirements (basic qualification requirements), Qualifications (education/experience), Skills (knowledge fields). No Benefits, Pay, Schedule.
We must not repeat job title as heading. No Job ID etc.
We must remove boilerplate like "Become a part of the Department..." maybe that's substantive? It's motivational but still part of posting. It's not boilerplate like EEO. We can keep as part of About the role.
We need to use - for any list of duties/requirements/benefits. So for duties list we need to extract bullet-like sentences. The duties summary is a paragraph; we could split into list items? The instruction: Use
- for any list of duties/requirements/benefits. If the content is not already a list, we could still format as list? Probably we should convert the enumerated duties into list items. The duties summary includes many sentences describing what investigators do. We can make each sentence a
- . Similarly for requirements (basic qualification requirements) maybe list? It's a paragraph. Could also list. For qualifications (education/experience) we have bullet-like options separated by "-OR-". Could make list.
Skills: list of knowledge fields.
We must preserve ALL substantive information; do not invent or summarize away detail. So we need to keep all details exactly as given, but we can reformat into HTML.
We must not add placeholder text 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 A (GS-11 equivalent)."
That seems like metadata about hiring authority, appointment type, pay table. Might be considered part of About the role or maybe not needed? It's substantive. We'll include in About the role.
Then: "Requirements 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 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 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- 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 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. 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.
About the role: could include the hiring authority paragraph and the mission statements about HHS, FDA, OII.
Responsibilities: duties summary (the paragraph after Basic Qualification Requirements? Actually the duties are described in the paragraph starting "This Investigator job family covers professional positions that conduct inspections..." That's more like a description of the role, but we can treat as Responsibilities.
Requirements: maybe the deadline and basic qualification requirements? But we have separate Qualifications for education/experience. Let's make:
- About the role: hiring authority, pay table, mission statements.
- Responsibilities: list of duties (investigators routinely examine products; collect samples; conduct inspections; apply critical thinking; maintain certification; provide outreach; may mentor; etc.)
- Requirements: maybe the basic qualification requirements paragraph (the description of the job family) but that seems more like responsibilities. Actually "Basic Qualification Requirements:" heading is followed by description of what the job family covers. That could be considered Requirements (what the job entails). But we already have Responsibilities. Might be overlapping. To avoid duplication, we could treat the "Basic Qualification Requirements:" as part of Requirements (the nature of the work). Then Responsibilities could be the specific duties list. However the text after that heading includes both description and duties. Let's parse:
"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."
Then after that: "Education/Experience Requirement: Candidates must meet one of the following: ..."
Thus we can treat:
- Requirements: the paragraph under "Basic Qualification Requirements:" (the description of the job family). Could be a
.
- Responsibilities: the list of specific duties (investigators routinely examine products; collect samples; conduct inspections; apply critical thinking; maintain certification; provide outreach; may mentor). Could be
.
- Qualifications: the education/experience requirement options (the four bullet options). Could be .
- Skills: the list of knowledge fields (biochemistry, biology, ...). Could be .
- About the role: the initial hiring authority paragraph and the mission statements about HHS, FDA
- for any list of duties/requirements/benefits. If the content is not already a list, we could still format as list? Probably we should convert the enumerated duties into list items. The duties summary includes many sentences describing what investigators do. We can make each sentence a
- . Similarly for requirements (basic qualification requirements) maybe list? It's a paragraph. Could also list. For qualifications (education/experience) we have bullet-like options separated by "-OR-". Could make list.
Skills: list of knowledge fields.
We must preserve ALL substantive information; do not invent or summarize away detail. So we need to keep all details exactly as given, but we can reformat into HTML.
We must not add placeholder text 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 A (GS-11 equivalent)."
That seems like metadata about hiring authority, appointment type, pay table. Might be considered part of About the role or maybe not needed? It's substantive. We'll include in About the role.
Then: "Requirements 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 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 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- 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 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. 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.
About the role: could include the hiring authority paragraph and the mission statements about HHS, FDA, OII.
Responsibilities: duties summary (the paragraph after Basic Qualification Requirements? Actually the duties are described in the paragraph starting "This Investigator job family covers professional positions that conduct inspections..." That's more like a description of the role, but we can treat as Responsibilities.
Requirements: maybe the deadline and basic qualification requirements? But we have separate Qualifications for education/experience. Let's make:
- About the role: hiring authority, pay table, mission statements.
- Responsibilities: list of duties (investigators routinely examine products; collect samples; conduct inspections; apply critical thinking; maintain certification; provide outreach; may mentor; etc.)
- Requirements: maybe the basic qualification requirements paragraph (the description of the job family) but that seems more like responsibilities. Actually "Basic Qualification Requirements:" heading is followed by description of what the job family covers. That could be considered Requirements (what the job entails). But we already have Responsibilities. Might be overlapping. To avoid duplication, we could treat the "Basic Qualification Requirements:" as part of Requirements (the nature of the work). Then Responsibilities could be the specific duties list. However the text after that heading includes both description and duties. Let's parse:
"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."
Then after that: "Education/Experience Requirement: Candidates must meet one of the following: ..."
Thus we can treat:
- Requirements: the paragraph under "Basic Qualification Requirements:" (the description of the job family). Could be a
. - Responsibilities: the list of specific duties (investigators routinely examine products; collect samples; conduct inspections; apply critical thinking; maintain certification; provide outreach; may mentor). Could be
- .
- Qualifications: the education/experience requirement options (the four bullet options). Could be
- .
- Skills: the list of knowledge fields (biochemistry, biology, ...). Could be
- .
- About the role: the initial hiring authority paragraph and the mission statements about HHS, FDA