Investigator II
for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must only include sections when posting has real specific content. The posting includes Duties Summary (which is responsibilities), Requirements Qualifications (which includes qualifications and basic qualification requirements). There's no explicit Benefits, Pay, Schedule. So we should not include those sections. Also we should not repeat job title as heading. The page already shows it. So we need headings for sections present: maybe "About the role" (duties summary), "Requirements", "Qualifications". However the posting lumps Requirements and Qualifications together. We could separate: "Requirements" for the deadline and maybe basic qualification requirements? But we need to follow instruction: use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can choose appropriate headings based on content.
We have Duties Summary: that's responsibilities. So we could use Responsibilities
. Then we have Requirements Qualifications: could be Requirements
and Qualifications
maybe. But we need to avoid thin sections. The content under Requirements includes deadline and basic qualification requirements description. Qualifications includes education/experience requirement details. Might be okay to split.
We must preserve all substantive information; do not invent or summarize away detail. Remove boilerplate: we need to remove cookie/navigation/legal/EEO etc. The text includes some motivational sentences like "Become a part of the Department..." etc. That's substantive? It's about the department, maybe considered boilerplate but it's descriptive of the agency. Might be considered part of the posting; but it's not duties or qualifications. It's more like "About the agency". Could be considered "About the role"? Not sure. The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The motivational paragraph about HHS and FDA is not boilerplate per se, it's describing the agency. Might be okay to keep as part of "About the role" or maybe a separate section like "About the agency". But we only have allowed headings list; we could put it under About the role
or maybe Responsibilities
includes duties summary only. The motivational paragraph is not duties. Could be considered "About the role" (general description). We'll include it under About the role
.
We need to use - for any list of duties/requirements/benefits. The duties summary is a paragraph; not a list. The qualifications includes bullet-like list? It's paragraphs with options separated by "-OR-". Not a list. We could keep as
. Only use lists if there is a list. There's no explicit bullet list. So we will not use
.
We need to preserve all substantive information: include deadline date, basic qualification requirements description, education/experience requirement options, note about transcripts, etc. Also include location info: Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Inspections and Investigations (OII), Office of Import Operations (OIO). Also mention OII professionals work in range of program areas and locations, with 196 offices throughout the United States. Also mention the position is being filled under streamlined hiring authority etc. That's part of duties summary? Actually it's at start: "Duties Summary This position is being filled under a stream-lined hiring authority..." That's more about the appointment type. Could be considered part of "About the role". We'll include that.
We must not include Job ID/requisition numbers as headings; none present.
We must not create Pay/Schedule/Benefits sections unless posting actually states them. Not present.
Thus output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications.
Let's craft:
About the role
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). 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.
Responsibilities
The Investigator II position conducts inspections in FDA regulated industries and prepares and submits 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.
Requirements
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.
Qualifications
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.
We used - for the list of options. That's appropriate.
We must ensure we didn't include any boilerplate like EEO etc. Not present.
Check for any duplicated lines: we have repeated some paragraphs about investigators in both Responsibilities and Basic Qualification Requirements. That's okay as they are from the posting; we must preserve all substantive information, not deduplicate. The instruction says remove duplicated lines, but that likely refers to boilerplate duplicates like "EEO" etc. The substantive duplication may be okay. However we have duplicated description of investigators in both Responsibilities and Basic Qualification Requirements. That's from the posting: the responsibilities section and
Responsibilities
. Then we have Requirements Qualifications: could beRequirements
andQualifications
maybe. But we need to avoid thin sections. The content under Requirements includes deadline and basic qualification requirements description. Qualifications includes education/experience requirement details. Might be okay to split. We must preserve all substantive information; do not invent or summarize away detail. Remove boilerplate: we need to remove cookie/navigation/legal/EEO etc. The text includes some motivational sentences like "Become a part of the Department..." etc. That's substantive? It's about the department, maybe considered boilerplate but it's descriptive of the agency. Might be considered part of the posting; but it's not duties or qualifications. It's more like "About the agency". Could be considered "About the role"? Not sure. The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The motivational paragraph about HHS and FDA is not boilerplate per se, it's describing the agency. Might be okay to keep as part of "About the role" or maybe a separate section like "About the agency". But we only have allowed headings list; we could put it underAbout the role
or maybeResponsibilities
includes duties summary only. The motivational paragraph is not duties. Could be considered "About the role" (general description). We'll include it underAbout the role
. We need to use- for any list of duties/requirements/benefits. The duties summary is a paragraph; not a list. The qualifications includes bullet-like list? It's paragraphs with options separated by "-OR-". Not a list. We could keep as
. Only use lists if there is a list. There's no explicit bullet list. So we will not use
- .
We need to preserve all substantive information: include deadline date, basic qualification requirements description, education/experience requirement options, note about transcripts, etc. Also include location info: Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Inspections and Investigations (OII), Office of Import Operations (OIO). Also mention OII professionals work in range of program areas and locations, with 196 offices throughout the United States. Also mention the position is being filled under streamlined hiring authority etc. That's part of duties summary? Actually it's at start: "Duties Summary This position is being filled under a stream-lined hiring authority..." That's more about the appointment type. Could be considered part of "About the role". We'll include that.
We must not include Job ID/requisition numbers as headings; none present.
We must not create Pay/Schedule/Benefits sections unless posting actually states them. Not present.
Thus output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications.
Let's craft:
- 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.
- for the list of options. That's appropriate. We must ensure we didn't include any boilerplate like EEO etc. Not present. Check for any duplicated lines: we have repeated some paragraphs about investigators in both Responsibilities and Basic Qualification Requirements. That's okay as they are from the posting; we must preserve all substantive information, not deduplicate. The instruction says remove duplicated lines, but that likely refers to boilerplate duplicates like "EEO" etc. The substantive duplication may be okay. However we have duplicated description of investigators in both Responsibilities and Basic Qualification Requirements. That's from the posting: the responsibilities section and
About the role
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). 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.
Responsibilities
The Investigator II position conducts inspections in FDA regulated industries and prepares and submits 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.
Requirements
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.
Qualifications
Education/Experience Requirement: Candidates must meet one of the following:
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.
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