Investigator II
for each section heading present. Use - for any list of duties/requirements/benefits. Use
for prose.
We need to preserve all substantive information, remove boilerplate like "Become a part of the Department..." maybe that's substantive? It's more like promotional but still part of posting. Should we keep? It's not boilerplate like EEO. It's okay to keep. But we need to remove duplicated lines, cookie/navigation/legal/EEO etc. There's none.
We need to include Duties Summary as Responsibilities? The instruction: use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should map content to appropriate headings. The posting has "Duties Summary" which is responsibilities. So we can use Responsibilities
. Then "Requirements Qualifications" maybe combine? There's a "Requirements" heading then "Qualifications". Could treat as Requirements section. Or separate? Probably combine into Requirements (includes qualifications). But we have both headings; we could output two sections: Requirements and Qualifications. However instruction: prefer a few substantive sections over many thin ones. But we have distinct content: Requirements (maybe generic) and Qualifications (education/experience). Could combine into one Requirements section that includes both. But we need to preserve all info; combining is fine as long as we don't lose detail.
We also have a paragraph about "Become a part of the Department..." which could be About the role? Could be placed under About the role. But we have no explicit About the role heading. Could create About the role section with that promotional paragraph. However instruction: include a section ONLY when the posting has real, specific content for it. The posting does have that paragraph, so we could create About the role.
Thus sections: About the role, Responsibilities, Requirements (or Qualifications). We'll decide.
Let's extract content:
Duties Summary 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 A (GS-11 equivalent)."
That's duties summary but also includes pay info (Title 21 Pay Table 1, Band A). Pay info is present, so we could create a Pay section. However the instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. Here we have pay table info. So we should include a Pay section with that info. But we also have duties summary content; we could split: Responsibilities section for duties description, Pay section for pay table.
But the duties summary also includes hiring authority etc. Might be more about the role. Could go to About the role.
Let's parse:
- Streamlined hiring authority details (legal basis)
- Career appointment, paid under provisions
- Position recruited based on Title 21 Pay Table 1, Band A (GS-11 equivalent)
That seems like pay and appointment type. Could be About the role.
Then after that, we have "Requirements Qualifications" heading then a long paragraph describing the Investigator job family, duties, etc. That's more responsibilities/duties.
Then "Education/Experience Requirement:" with bullet-like options (though not formatted as list). We need to turn into - .
Then after that: "NOTE: Applicants must submit all relevant transcripts..." that's a note.
Then promotional paragraph about HHS, FDA, etc.
Then location info: "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."
That could be About the role or Responsibilities? It's about location and office description.
We need to decide sections.
Potential sections:
- About the role: includes hiring authority, appointment type, pay table, location, office description.
- Responsibilities: duties summary (the long paragraph about investigator job family, inspections, etc.)
- Requirements: education/experience requirements (the list)
- Qualifications: maybe not needed if we combine.
But we have both Requirements and Qualifications headings in source. Could treat Requirements as generic (maybe none) and Qualifications as education/experience. However the source lumps them together: "Requirements Qualifications" then paragraph about job family then Education/Experience Requirement. So we could make a single section "Qualifications" containing both the job family description and education/experience.
But 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 if content exists.
We have content for Requirements? The "Requirements" heading is followed immediately by "Qualifications". There's no separate requirement list besides the education/experience. So maybe we treat the whole block as Qualifications.
Thus sections: About the role, Responsibilities, Qualifications.
We also have Pay info; we could embed Pay in About the role or create Pay section. Since we have explicit pay table, better to create Pay section.
Thus sections: About the role, Responsibilities, Pay, Qualifications.
Check if any schedule info: none.
Benefits: none.
Skills: none explicit.
Thus output:
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). 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 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.
Pay
This position is being recruited based on the Title 21 Pay Table 1, Band A (GS-11 equivalent).
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;
- 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;
- 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;
- 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.
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
We should also include the sentence "Become a part of the Department that touches the lives of every American..." maybe we omitted. That is promotional; could be placed in About the role. Let's add that paragraph after location info.
Add to About the role paragraph: after location info, add: "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."
Thus About the role includes all that.
Now ensure
for prose. We need to preserve all substantive information, remove boilerplate like "Become a part of the Department..." maybe that's substantive? It's more like promotional but still part of posting. Should we keep? It's not boilerplate like EEO. It's okay to keep. But we need to remove duplicated lines, cookie/navigation/legal/EEO etc. There's none. We need to include Duties Summary as Responsibilities? The instruction: use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should map content to appropriate headings. The posting has "Duties Summary" which is responsibilities. So we can use Responsibilities
. Then "Requirements Qualifications" maybe combine? There's a "Requirements" heading then "Qualifications". Could treat as Requirements section. Or separate? Probably combine into Requirements (includes qualifications). But we have both headings; we could output two sections: Requirements and Qualifications. However instruction: prefer a few substantive sections over many thin ones. But we have distinct content: Requirements (maybe generic) and Qualifications (education/experience). Could combine into one Requirements section that includes both. But we need to preserve all info; combining is fine as long as we don't lose detail.
We also have a paragraph about "Become a part of the Department..." which could be About the role? Could be placed under About the role. But we have no explicit About the role heading. Could create About the role section with that promotional paragraph. However instruction: include a section ONLY when the posting has real, specific content for it. The posting does have that paragraph, so we could create About the role.
Thus sections: About the role, Responsibilities, Requirements (or Qualifications). We'll decide.
Let's extract content:
Duties Summary 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 A (GS-11 equivalent)."
That's duties summary but also includes pay info (Title 21 Pay Table 1, Band A). Pay info is present, so we could create a Pay section. However the instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. Here we have pay table info. So we should include a Pay section with that info. But we also have duties summary content; we could split: Responsibilities section for duties description, Pay section for pay table.
But the duties summary also includes hiring authority etc. Might be more about the role. Could go to About the role.
Let's parse:
- Streamlined hiring authority details (legal basis)
- Career appointment, paid under provisions
- Position recruited based on Title 21 Pay Table 1, Band A (GS-11 equivalent)
That seems like pay and appointment type. Could be About the role.
Then after that, we have "Requirements Qualifications" heading then a long paragraph describing the Investigator job family, duties, etc. That's more responsibilities/duties.
Then "Education/Experience Requirement:" with bullet-like options (though not formatted as list). We need to turn into - .
Then after that: "NOTE: Applicants must submit all relevant transcripts..." that's a note.
Then promotional paragraph about HHS, FDA, etc.
Then location info: "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."
That could be About the role or Responsibilities? It's about location and office description.
We need to decide sections.
Potential sections:
- About the role: includes hiring authority, appointment type, pay table, location, office description.
- Responsibilities: duties summary (the long paragraph about investigator job family, inspections, etc.)
- Requirements: education/experience requirements (the list)
- Qualifications: maybe not needed if we combine.
But we have both Requirements and Qualifications headings in source. Could treat Requirements as generic (maybe none) and Qualifications as education/experience. However the source lumps them together: "Requirements Qualifications" then paragraph about job family then Education/Experience Requirement. So we could make a single section "Qualifications" containing both the job family description and education/experience.
But 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 if content exists.
We have content for Requirements? The "Requirements" heading is followed immediately by "Qualifications". There's no separate requirement list besides the education/experience. So maybe we treat the whole block as Qualifications.
Thus sections: About the role, Responsibilities, Qualifications.
We also have Pay info; we could embed Pay in About the role or create Pay section. Since we have explicit pay table, better to create Pay section.
Thus sections: About the role, Responsibilities, Pay, Qualifications.
Check if any schedule info: none.
Benefits: none.
Skills: none explicit.
Thus output:
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). 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 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.
Pay
This position is being recruited based on the Title 21 Pay Table 1, Band A (GS-11 equivalent).
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;
- 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;
- 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;
- 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.
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
We should also include the sentence "Become a part of the Department that touches the lives of every American..." maybe we omitted. That is promotional; could be placed in About the role. Let's add that paragraph after location info.
Add to About the role paragraph: after location info, add: "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."
Thus About the role includes all that.
Now ensure
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have both Requirements and Qualifications if content exists.
We have content for Requirements? The "Requirements" heading is followed immediately by "Qualifications". There's no separate requirement list besides the education/experience. So maybe we treat the whole block as Qualifications.
Thus sections: About the role, Responsibilities, Qualifications.
We also have Pay info; we could embed Pay in About the role or create Pay section. Since we have explicit pay table, better to create Pay section.
Thus sections: About the role, Responsibilities, Pay, Qualifications.
Check if any schedule info: none.
Benefits: none.
Skills: none explicit.
Thus output:
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). 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 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.
Pay
This position is being recruited based on the Title 21 Pay Table 1, Band A (GS-11 equivalent).
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;
- 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;
- 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;
- 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.
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
We should also include the sentence "Become a part of the Department that touches the lives of every American..." maybe we omitted. That is promotional; could be placed in About the role. Let's add that paragraph after location info. Add to About the role paragraph: after location info, add: "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." Thus About the role includes all that. Now ensure