Senior Investigator I
FDA · Anchorage, AK · 1 mo ago
Full-time
We need to output HTML fragment with sections: headings for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Use
for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Use - for any list of duties/requirements/benefits, and
for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove boilerplate etc. Include a section ONLY when posting has real, specific content for it — never emit heading followed by filler/placeholder text. Prefer few substantive sections over many thin ones.
We need to parse the posting.
Content:
- Duties Summary: includes description of authority, appointment, pay table, etc. This is more about the position context. Could be "About the role" or "Responsibilities"? The duties summary includes description of authority, appointment, pay table, location, etc. Might be considered "About the role". Then later there is "Requirements Qualifications" which includes basic qualification requirements, education/experience requirement, etc. That is qualifications.
There is no explicit "Responsibilities" list of duties; the duties summary includes description of what investigators do: examine products, collect samples, conduct inspections, etc. That could be responsibilities. So we could have a "Responsibilities" section with bullet list of duties.
We also have "Qualifications" section with bullet list of education/experience requirements.
We have no explicit "Skills", "Benefits", "Pay", "Schedule". The posting mentions pay: "This position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent)." That's specific pay info. So we should include a Pay section with that detail. Also maybe location? Not required but could be part of About the role.
We have no explicit benefits. So we should not create Benefits section unless posting states them. It does not.
Schedule: not mentioned.
Skills: not explicit list; but we could infer from qualifications but better not to create unless explicit.
Thus sections: About the role (or maybe Summary), Responsibilities, Qualifications, Pay.
We need to use
for each section heading.
Inside sections, use
for prose,
- for lists.
We must preserve all substantive information. Let's extract.
From 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 B (GS-12 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."
Also earlier: "Become a part of the Department that touches the lives of every American..." that's motivational but maybe considered boilerplate? It's not EEO but still promotional. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. This motivational paragraph may be considered boilerplate? It's not EEO but still generic. Might be considered fluff. However it's substantive? It's about HHS mission. Could be considered part of About the role. The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. So we should keep it if it's not boilerplate. It's about HHS mission; could be considered substantive. We'll keep.
Now responsibilities: from the Basic Qualification Requirements paragraph: "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."
That's a long paragraph describing duties. We can turn into bullet list for clarity. But we must preserve all substantive information; we can keep as prose or list. The instruction: Use
- for any list of duties/requirements/benefits. So we should convert duties into a list. However we need to ensure we don't lose any detail. We'll break into bullet points each covering a distinct duty.
Let's extract bullet points:
- Conduct inspections in FDA-regulated industries.
- Prepare and submit reports accompanied by supporting evidence documenting violations of the FD&C Act and other laws, regulations, and requirements administered by FDA.
- Investigate and/or inspect FDA-regulated industry globally.
- Evaluate compliance with U.S. laws and regulations to promote a culture of safety and quality.
- Objective: prevent unsafe, ineffective, and/or defective products from reaching patients/consumers or being used in clinical trials.
- Facilitate appropriate development of novel products.
- FDA's enforcement protects patients/consumers from impure, unsafe, ineffective, improperly or deceptively labeled/packaged, or otherwise dangerous/defective products.
- Routinely examine products.
- Collect samples.
- Conduct inspections of establishments that design, make, process, hold, or distribute FDA-regulated products.
- Gather information and evidence to document objectionable conditions and assess compliance with U.S. law and regulations.
- Apply critical thinking to evaluate manufacturing processes, design practices, facility and material controls, supply chains, quality management systems, laboratory analyses, and clinical investigation programs.
- Assess compliance with U.S. laws and regulations and support advancements and innovations.
- Continuously maintain required certification and credentials.
- Provide internal and external stakeholder outreach, assistance, and education.
- May mentor less experienced personnel.
Also mention knowledge of various scientific fields: "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." That could be part of qualifications or skills. Since it's a requirement, we could include in Qualifications section as bullet.
Now qualifications section: Education and/or Experience Requirement with bullet options.
We need to preserve all detail: list of degree fields, years of experience, etc.
We'll create a
with each option as - . Also include note about transcripts.
Also include "Become a part of the Department..." paragraph maybe as part of About the role.
Now Pay section: include the pay table statement.
Now About the role section: include the hiring authority, appointment, location, OII description, HHS mission paragraph.
We must not repeat job title as heading. No job title given explicitly; but we can ignore.
Now ensure we don't create sections with filler. All sections have content.
Now produce HTML fragment.
Let's craft.
Structure:
About the role
... (combined paragraphs)
Responsibilities
- ...
...
Qualifications
Education and/or Experience Requirement: Candidates must meet one of the following:
- ...
...
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Pay
This position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent).
We might also include location in About the role.
Now check for any duplicated lines: we need to avoid duplication. Ensure we don't repeat same sentence.
Now produce final HTML.
Let's write the About the role 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. 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. 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."
That seems fine.
Now Responsibilities bullets as earlier.
Now Qualifications bullets: need to include the four options.
Option 1: 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 three 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.
Option 2: Master's degree or higher in same fields, with two years comparable experience.
Option 3: Doctorate degree or higher in same fields, with one year comparable experience.
Option 4: Five 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
for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove boilerplate etc. Include a section ONLY when posting has real, specific content for it — never emit heading followed by filler/placeholder text. Prefer few substantive sections over many thin ones. We need to parse the posting. Content: - Duties Summary: includes description of authority, appointment, pay table, etc. This is more about the position context. Could be "About the role" or "Responsibilities"? The duties summary includes description of authority, appointment, pay table, location, etc. Might be considered "About the role". Then later there is "Requirements Qualifications" which includes basic qualification requirements, education/experience requirement, etc. That is qualifications. There is no explicit "Responsibilities" list of duties; the duties summary includes description of what investigators do: examine products, collect samples, conduct inspections, etc. That could be responsibilities. So we could have a "Responsibilities" section with bullet list of duties. We also have "Qualifications" section with bullet list of education/experience requirements. We have no explicit "Skills", "Benefits", "Pay", "Schedule". The posting mentions pay: "This position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent)." That's specific pay info. So we should include a Pay section with that detail. Also maybe location? Not required but could be part of About the role. We have no explicit benefits. So we should not create Benefits section unless posting states them. It does not. Schedule: not mentioned. Skills: not explicit list; but we could infer from qualifications but better not to create unless explicit. Thus sections: About the role (or maybe Summary), Responsibilities, Qualifications, Pay. We need to use
for each section heading. Inside sections, use
for prose,
- for lists.
We must preserve all substantive information. Let's extract.
From 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 B (GS-12 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."
Also earlier: "Become a part of the Department that touches the lives of every American..." that's motivational but maybe considered boilerplate? It's not EEO but still promotional. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. This motivational paragraph may be considered boilerplate? It's not EEO but still generic. Might be considered fluff. However it's substantive? It's about HHS mission. Could be considered part of About the role. The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. So we should keep it if it's not boilerplate. It's about HHS mission; could be considered substantive. We'll keep.
Now responsibilities: from the Basic Qualification Requirements paragraph: "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."
That's a long paragraph describing duties. We can turn into bullet list for clarity. But we must preserve all substantive information; we can keep as prose or list. The instruction: Use
- for any list of duties/requirements/benefits. So we should convert duties into a list. However we need to ensure we don't lose any detail. We'll break into bullet points each covering a distinct duty.
Let's extract bullet points:
- Conduct inspections in FDA-regulated industries.
- Prepare and submit reports accompanied by supporting evidence documenting violations of the FD&C Act and other laws, regulations, and requirements administered by FDA.
- Investigate and/or inspect FDA-regulated industry globally.
- Evaluate compliance with U.S. laws and regulations to promote a culture of safety and quality.
- Objective: prevent unsafe, ineffective, and/or defective products from reaching patients/consumers or being used in clinical trials.
- Facilitate appropriate development of novel products.
- FDA's enforcement protects patients/consumers from impure, unsafe, ineffective, improperly or deceptively labeled/packaged, or otherwise dangerous/defective products.
- Routinely examine products.
- Collect samples.
- Conduct inspections of establishments that design, make, process, hold, or distribute FDA-regulated products.
- Gather information and evidence to document objectionable conditions and assess compliance with U.S. law and regulations.
- Apply critical thinking to evaluate manufacturing processes, design practices, facility and material controls, supply chains, quality management systems, laboratory analyses, and clinical investigation programs.
- Assess compliance with U.S. laws and regulations and support advancements and innovations.
- Continuously maintain required certification and credentials.
- Provide internal and external stakeholder outreach, assistance, and education.
- May mentor less experienced personnel.
Also mention knowledge of various scientific fields: "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." That could be part of qualifications or skills. Since it's a requirement, we could include in Qualifications section as bullet.
Now qualifications section: Education and/or Experience Requirement with bullet options.
We need to preserve all detail: list of degree fields, years of experience, etc.
We'll create a
- with each option as
- . Also include note about transcripts.
Also include "Become a part of the Department..." paragraph maybe as part of About the role.
Now Pay section: include the pay table statement.
Now About the role section: include the hiring authority, appointment, location, OII description, HHS mission paragraph.
We must not repeat job title as heading. No job title given explicitly; but we can ignore.
Now ensure we don't create sections with filler. All sections have content.
Now produce HTML fragment.
Let's craft.
Structure:
About the role
... (combined paragraphs)
Responsibilities
- ... ...
Qualifications
Education and/or Experience Requirement: Candidates must meet one of the following:
- ... ...
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Pay
This position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent).
We might also include location in About the role. Now check for any duplicated lines: we need to avoid duplication. Ensure we don't repeat same sentence. Now produce final HTML. Let's write the About the role 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. 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. 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." That seems fine. Now Responsibilities bullets as earlier. Now Qualifications bullets: need to include the four options. Option 1: 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 three 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. Option 2: Master's degree or higher in same fields, with two years comparable experience. Option 3: Doctorate degree or higher in same fields, with one year comparable experience. Option 4: Five 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
- . Also include note about transcripts.
Also include "Become a part of the Department..." paragraph maybe as part of About the role.
Now Pay section: include the pay table statement.
Now About the role section: include the hiring authority, appointment, location, OII description, HHS mission paragraph.
We must not repeat job title as heading. No job title given explicitly; but we can ignore.
Now ensure we don't create sections with filler. All sections have content.
Now produce HTML fragment.
Let's craft.
Structure:
- for any list of duties/requirements/benefits. So we should convert duties into a list. However we need to ensure we don't lose any detail. We'll break into bullet points each covering a distinct duty.
Let's extract bullet points:
- Conduct inspections in FDA-regulated industries.
- Prepare and submit reports accompanied by supporting evidence documenting violations of the FD&C Act and other laws, regulations, and requirements administered by FDA.
- Investigate and/or inspect FDA-regulated industry globally.
- Evaluate compliance with U.S. laws and regulations to promote a culture of safety and quality.
- Objective: prevent unsafe, ineffective, and/or defective products from reaching patients/consumers or being used in clinical trials.
- Facilitate appropriate development of novel products.
- FDA's enforcement protects patients/consumers from impure, unsafe, ineffective, improperly or deceptively labeled/packaged, or otherwise dangerous/defective products.
- Routinely examine products.
- Collect samples.
- Conduct inspections of establishments that design, make, process, hold, or distribute FDA-regulated products.
- Gather information and evidence to document objectionable conditions and assess compliance with U.S. law and regulations.
- Apply critical thinking to evaluate manufacturing processes, design practices, facility and material controls, supply chains, quality management systems, laboratory analyses, and clinical investigation programs.
- Assess compliance with U.S. laws and regulations and support advancements and innovations.
- Continuously maintain required certification and credentials.
- Provide internal and external stakeholder outreach, assistance, and education.
- May mentor less experienced personnel.
Also mention knowledge of various scientific fields: "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." That could be part of qualifications or skills. Since it's a requirement, we could include in Qualifications section as bullet.
Now qualifications section: Education and/or Experience Requirement with bullet options.
We need to preserve all detail: list of degree fields, years of experience, etc.
We'll create a