Senior Investigator I
FDA · Newark, NJ · 1 mo ago
Information TechnologyFull-time
We need to output HTML fragment with sections: headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must only include sections that have real specific content. The posting includes Duties Summary (which is responsibilities), Requirements, Qualifications (some overlapping). There's no explicit Benefits, Pay, Schedule. So we should not include those headings. We need to preserve all substantive info, no boilerplate. Remove cookie/navigation/legal/EEO etc. The text includes some motivational paragraphs about HHS, FDA etc. Those are substantive? They are descriptive of agency, maybe considered "About the role" or "About the organization". We can put them under a section like "About the role" or "About the organization". The instruction: use
for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must only include sections that have real specific content. The posting includes Duties Summary (which is responsibilities), Requirements, Qualifications (some overlapping). There's no explicit Benefits, Pay, Schedule. So we should not include those headings. We need to preserve all substantive info, no boilerplate. Remove cookie/navigation/legal/EEO etc. The text includes some motivational paragraphs about HHS, FDA etc. Those are substantive? They are descriptive of agency, maybe considered "About the role" or "About the organization". We can put them under a section like "About the role" or "About the organization". The 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 (responsibilities). We have Requirements Qualifications (qualifications). Also there is description of the job family, basic qualification requirements, education/experience requirement. That's qualifications.
We also have some paragraphs about HHS mission, FDA description, location, OII. That could be "About the role" or "About the organization". Since we cannot repeat job title as heading, but we can have About the role.
We need to use - for any list of duties/requirements/benefits. The posting does not have explicit bullet lists; it's prose. So we may not need lists unless we convert sentences into list items? The instruction: Use
- for any list of duties/requirements/benefits. If there is no explicit list, we can keep prose in
. So we will keep paragraphs.
We must not include placeholders like "commensurate with experience". Not present.
We must not include Job ID/requisition numbers. Not present.
We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines. The text includes some motivational paragraphs but not boilerplate. There's a line: "Become a part of the Department that touches the lives of every American." That's okay.
We need to preserve all substantive information. So we need to include everything except boilerplate. Let's identify any boilerplate: The text includes "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." That's substantive (hiring authority). Keep.
"The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority." Keep.
"This position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent)." This mentions pay table but not actual pay amount. It's a reference to pay table; but we should not create a Pay section unless posting actually states them. It does not give a specific salary range, just says based on Title 21 Pay Table 1, Band B (GS-12 equivalent). That's still pay info but not a specific number. The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. It does state the pay table reference, but not actual pay. Might be considered stating them? It's ambiguous. Safer to not create a Pay section; we can include that sentence in the About the role or Responsibilities? It's about compensation. Could be placed in a
under About the role. Since we are not making a Pay heading, it's okay.
We must not include schedule info; none.
Now structure:
About the role
... include the hiring authority paragraph, career appointment, pay table reference, location description, mission statements, FDA description, OII details.
Responsibilities
... Duties Summary paragraph (the long description of investigator duties).
Qualifications
... Basic Qualification Requirements paragraph (the description of investigator job family).
... Education and/or Experience Requirement paragraph (the four options).
... NOTE about transcripts.
We could also have a Requirements
but we have Qualifications; the posting uses both Requirements and Qualifications headings. We could combine them under Qualifications. The instruction: use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we could have both Requirements and Qualifications if content distinct. The posting has "Requirements Qualifications" as a heading then "Basic Qualification Requirements:" and "Education and/or Experience Requirement:" So we could treat that as Qualifications. The earlier "Duties Summary" is responsibilities. There's no separate Requirements beyond that. So we can just have Qualifications.
We must not repeat job title as heading. Not needed.
We must output only HTML fragment, no /, no markdown.
Let's craft.
We need to ensure we preserve all substantive info. Let's extract paragraphs:
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 B (GS-12 equivalent)."
Then after that: "Requirements Qualifications In order to qualify for the Senior Investigator I position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 10/01/2026: Basic Qualification Requirements: This Investigator job family covers professional positions that conduct inspections in FDA regulated industries and prepare and submit reports accompanied by supporting evidence documenting violations of the FD&C Act and other laws, regulations, and requirements administered by FDA. The position investigates and/or inspects FDA-regulated industry globally and evaluates compliance with U.S. laws and regulations in order to promote a culture of safety and quality with the objective of preventing unsafe, ineffective and/or defective products from becoming available to patients and consumers or used in clinical trials while facilitating appropriate development of novel products. FDA's enforcement of the laws and regulations protects patients and consumers from products that are impure, unsafe, ineffective, improperly or deceptively labeled or packaged, or in some other way dangerous or defective. Investigators routinely examine products; collect samples; conduct inspections of establishments that design, make, process, hold, or distribute FDA-regulated products; and otherwise gather information and evidence to document objectionable conditions and assess compliance with U.S. law and regulations. Investigators apply critical thinking to evaluate manufacturing processes, design practices, facility and material controls, supply chains, quality management systems, laboratory analyses, and clinical investigation programs to assess compliance with U.S. laws and regulations and to support advancements and innovations. Investigators continuously maintain required certification and credentials; provide internal and external stakeholder outreach, assistance, and education; and may mentor less experienced personnel. These positions require knowledge of various scientific fields such as biochemistry, biology, biotechnology, chemistry, data science, digital health, engineering, epidemiology, food engineering, food processing technologies, food safety, healthcare, medical technology, microbiology, nutrition, pharmaceutical science, pharmacology, public health, quality assurance, and quality management. Education and/or 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 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; -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 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- 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 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- 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 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: includes hiring authority paragraph, career appointment, pay table reference, location, mission statements, FDA description, OII details. Also maybe the "Become a part..." paragraph.
Responsibilities: The Duties Summary paragraph (the long description of investigator duties). Actually the Duties Summary paragraph includes the hiring authority etc? Wait the first paragraph after "Duties Summary" includes hiring authority etc. Actually the text: "Duties Summary This position is being filled under a stream-lined hiring authority..." So the Duties Summary includes hiring authority etc. But then later there is "Requirements Qualifications ..." So the duties summary includes both hiring authority and the description of the role? Let's parse: The heading "Duties Summary" then the sentence: "This position is being filled under a stream-lined hiring authority..." That seems more about appointment type than duties.
- for any list of duties/requirements/benefits. The posting does not have explicit bullet lists; it's prose. So we may not need lists unless we convert sentences into list items? The instruction: Use
- for any list of duties/requirements/benefits. If there is no explicit list, we can keep prose in
. So we will keep paragraphs. We must not include placeholders like "commensurate with experience". Not present. We must not include Job ID/requisition numbers. Not present. We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines. The text includes some motivational paragraphs but not boilerplate. There's a line: "Become a part of the Department that touches the lives of every American." That's okay. We need to preserve all substantive information. So we need to include everything except boilerplate. Let's identify any boilerplate: The text includes "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." That's substantive (hiring authority). Keep. "The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority." Keep. "This position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent)." This mentions pay table but not actual pay amount. It's a reference to pay table; but we should not create a Pay section unless posting actually states them. It does not give a specific salary range, just says based on Title 21 Pay Table 1, Band B (GS-12 equivalent). That's still pay info but not a specific number. The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. It does state the pay table reference, but not actual pay. Might be considered stating them? It's ambiguous. Safer to not create a Pay section; we can include that sentence in the About the role or Responsibilities? It's about compensation. Could be placed in a
under About the role. Since we are not making a Pay heading, it's okay. We must not include schedule info; none. Now structure:
About the role
... include the hiring authority paragraph, career appointment, pay table reference, location description, mission statements, FDA description, OII details.
Responsibilities
... Duties Summary paragraph (the long description of investigator duties).
Qualifications
... Basic Qualification Requirements paragraph (the description of investigator job family).
... Education and/or Experience Requirement paragraph (the four options).
... NOTE about transcripts.
We could also have aRequirements
but we have Qualifications; the posting uses both Requirements and Qualifications headings. We could combine them under Qualifications. The instruction: use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we could have both Requirements and Qualifications if content distinct. The posting has "Requirements Qualifications" as a heading then "Basic Qualification Requirements:" and "Education and/or Experience Requirement:" So we could treat that as Qualifications. The earlier "Duties Summary" is responsibilities. There's no separate Requirements beyond that. So we can just have Qualifications. We must not repeat job title as heading. Not needed. We must output only HTML fragment, no /, no markdown. Let's craft. We need to ensure we preserve all substantive info. Let's extract paragraphs: 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 B (GS-12 equivalent)." Then after that: "Requirements Qualifications In order to qualify for the Senior Investigator I position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 10/01/2026: Basic Qualification Requirements: This Investigator job family covers professional positions that conduct inspections in FDA regulated industries and prepare and submit reports accompanied by supporting evidence documenting violations of the FD&C Act and other laws, regulations, and requirements administered by FDA. The position investigates and/or inspects FDA-regulated industry globally and evaluates compliance with U.S. laws and regulations in order to promote a culture of safety and quality with the objective of preventing unsafe, ineffective and/or defective products from becoming available to patients and consumers or used in clinical trials while facilitating appropriate development of novel products. FDA's enforcement of the laws and regulations protects patients and consumers from products that are impure, unsafe, ineffective, improperly or deceptively labeled or packaged, or in some other way dangerous or defective. Investigators routinely examine products; collect samples; conduct inspections of establishments that design, make, process, hold, or distribute FDA-regulated products; and otherwise gather information and evidence to document objectionable conditions and assess compliance with U.S. law and regulations. Investigators apply critical thinking to evaluate manufacturing processes, design practices, facility and material controls, supply chains, quality management systems, laboratory analyses, and clinical investigation programs to assess compliance with U.S. laws and regulations and to support advancements and innovations. Investigators continuously maintain required certification and credentials; provide internal and external stakeholder outreach, assistance, and education; and may mentor less experienced personnel. These positions require knowledge of various scientific fields such as biochemistry, biology, biotechnology, chemistry, data science, digital health, engineering, epidemiology, food engineering, food processing technologies, food safety, healthcare, medical technology, microbiology, nutrition, pharmaceutical science, pharmacology, public health, quality assurance, and quality management. Education and/or 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 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; -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 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- 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 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- 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 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: includes hiring authority paragraph, career appointment, pay table reference, location, mission statements, FDA description, OII details. Also maybe the "Become a part..." paragraph. Responsibilities: The Duties Summary paragraph (the long description of investigator duties). Actually the Duties Summary paragraph includes the hiring authority etc? Wait the first paragraph after "Duties Summary" includes hiring authority etc. Actually the text: "Duties Summary This position is being filled under a stream-lined hiring authority..." So the Duties Summary includes hiring authority etc. But then later there is "Requirements Qualifications ..." So the duties summary includes both hiring authority and the description of the role? Let's parse: The heading "Duties Summary" then the sentence: "This position is being filled under a stream-lined hiring authority..." That seems more about appointment type than duties.
- for any list of duties/requirements/benefits. If there is no explicit list, we can keep prose in