Senior Investigator I
FDA · Alameda, CA · 1 mo ago
OTHRFull-time
We need to output HTML fragment with sections: headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Use
for sections 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. Remove boilerplate, duplicated lines, application instructions. Include a section ONLY when posting has real, specific content for it. Avoid filler like "commensurate with experience". No Pay/Schedule/Benefits unless stated. The posting includes Duties Summary (which is like responsibilities), Requirements Qualifications (which includes basic qualification requirements, education/experience). No explicit Benefits, Pay, Schedule. So we should have sections: maybe "About the role" (could be from description of position), "Responsibilities" (duties summary), "Requirements" (basic qualification requirements), "Qualifications" (education/experience). But we must not duplicate. The instructions: use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can choose appropriate ones based on content.
We have content: Duties Summary (description of role, authority, pay table). That could be "About the role". Then "Responsibilities" could be the list of duties (investigates, inspects, etc). Then "Requirements" could be the basic qualification requirements description. Then "Qualifications" could be the education/experience requirement list.
We must not repeat job title. No metadata like Job ID.
We need to preserve all substantive information. So we need to include the details: streamlined hiring authority, Title 21 US Code etc, career appointment, pay under provisions, Title 21 Pay Table 1 Band B (GS-12 equivalent). Also mention location: 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 description.
We need to format as HTML fragment only.
We need to use
for each section heading. Inside sections, use
for prose,
- for lists.
We need to avoid duplication. Let's extract substantive content.
From the 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 later: "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)." plus description of OII.
Responsibilities (duties):
From the paragraph after 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."
That's a long prose; we can break into bullet list for duties? The instruction: Use
- for any list of duties/requirements/benefits. So we could turn the duties into a list. But we need to preserve all substantive information; we can either keep as prose or list. Probably better to list each duty as
- . However we must not lose any detail. 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 becoming available to patients and consumers or used in clinical trials
- Facilitate appropriate development of novel products
- FDA's enforcement protects patients and consumers from products that are impure, unsafe, ineffective, improperly or deceptively labeled or packaged, or otherwise dangerous or defective
- 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 to assess compliance with U.S. laws and regulations and to 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: 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 requirements.
Now Requirements Qualifications section: "Basic Qualification Requirements: This Investigator job family covers professional positions that conduct inspections..." Actually that seems overlapping with duties. But we have separate "Basic Qualification Requirements:" paragraph that describes the job family. Might be considered part of requirements.
Then "Education and/or Experience Requirement:" with bullet options.
We need to capture that.
Also note: "NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications." That's a requirement.
Also motivational paragraphs: "Become a part of the Department that touches the lives of every American..." etc. That's more about the agency; could be "About the role" or maybe we can include in "About the role". But we should not include boilerplate like EEO etc. This is motivational but still substantive? It's about HHS mission. Might be considered part of "About the role". We'll include.
Also description of OII: "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's substantive.
Now we need to decide sections.
Potential sections:
- About the role: includes hiring authority, appointment type, pay table, location, agency description, OII description, motivational HHS mission.
- Responsibilities: list of duties (as above).
- Requirements: includes basic qualification requirements description (job family) and note about transcripts.
- Qualifications: education/experience requirements (the four options) plus knowledge of scientific fields.
We should not create Skills section unless present; not present.
We should not create Benefits, Pay, Schedule unless present; we have pay table info but that's about pay band; but the instruction says never create Pay/Schedule/Benefits sections unless the posting actually states them. It does state pay table: "This position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent)." That is pay info. Should we include a Pay section? The instruction: "never create Pay/Schedule/Benefits sections unless the posting actually states them." It does state pay table, so we could include a Pay section. However they also said "Prefer a few substantive sections over many thin ones." Could embed pay info in About the role. But they said include a section ONLY when posting has real, specific content for it. The pay table is specific content. So we could either include a Pay section or include it in About the role. The instruction: "Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So they expect those as possible headings. If we include Pay, we must have real content. We have that. So we could add a Pay section with that line.
Similarly, Schedule not present, Benefits not present.
Thus sections: About the role, Responsibilities, Requirements, Qualifications, Pay.
We must avoid duplication. Ensure we don't repeat same info in multiple sections.
Let's craft.
About the role: include hiring authority, appointment type, location (DHHS, FDA, OII, OIO), OII description, HHS mission motivational paragraph.
Responsibilities: bullet list of duties (the long list). Also maybe include the objective statement about preventing unsafe products etc. Could be part of duties.
Requirements: basic qualification requirements description (the paragraph that starts "This Investigator job family covers professional positions...") plus note about transcripts.
Qualifications: education/experience requirements (the four options) plus knowledge of scientific fields list.
Pay: mention Title 21 Pay Table 1, Band B (GS-12 equivalent).
We need to ensure we preserve all substantive information: also mention that candidate will be paid under provisions of this authority (already in About the role). Also mention career or career-conditional appointment.
Also mention that the position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent). Already in Pay.
Also mention that the position is located in DHHS, FDA, OII, OIO.
Also mention OII professionals work in range of program areas and locations, with 196 offices throughout US.
Also mention that the position investigates and/or inspects FDA-regulated industry globally etc.
Also mention that investigators 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 list.
Also mention that the 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.
Also mention that the candidate selected will serve under a career or career-conditional appointment and be paid under the provisions of this authority.
Also mention that the position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent). Already.
Also mention that the position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent). Already.
Also mention that the position is being recruited based on the Title 21 Pay Table 1, Band
for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Remove boilerplate, duplicated lines, application instructions. Include a section ONLY when posting has real, specific content for it. Avoid filler like "commensurate with experience". No Pay/Schedule/Benefits unless stated. The posting includes Duties Summary (which is like responsibilities), Requirements Qualifications (which includes basic qualification requirements, education/experience). No explicit Benefits, Pay, Schedule. So we should have sections: maybe "About the role" (could be from description of position), "Responsibilities" (duties summary), "Requirements" (basic qualification requirements), "Qualifications" (education/experience). But we must not duplicate. The instructions: use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can choose appropriate ones based on content. We have content: Duties Summary (description of role, authority, pay table). That could be "About the role". Then "Responsibilities" could be the list of duties (investigates, inspects, etc). Then "Requirements" could be the basic qualification requirements description. Then "Qualifications" could be the education/experience requirement list. We must not repeat job title. No metadata like Job ID. We need to preserve all substantive information. So we need to include the details: streamlined hiring authority, Title 21 US Code etc, career appointment, pay under provisions, Title 21 Pay Table 1 Band B (GS-12 equivalent). Also mention location: 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 description. We need to format as HTML fragment only. We need to use
for each section heading. Inside sections, use
for prose,
- for lists.
We need to avoid duplication. Let's extract substantive content.
From the 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 later: "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)." plus description of OII.
Responsibilities (duties):
From the paragraph after 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."
That's a long prose; we can break into bullet list for duties? The instruction: Use
- for any list of duties/requirements/benefits. So we could turn the duties into a list. But we need to preserve all substantive information; we can either keep as prose or list. Probably better to list each duty as
- . However we must not lose any detail. 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 becoming available to patients and consumers or used in clinical trials
- Facilitate appropriate development of novel products
- FDA's enforcement protects patients and consumers from products that are impure, unsafe, ineffective, improperly or deceptively labeled or packaged, or otherwise dangerous or defective
- 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 to assess compliance with U.S. laws and regulations and to 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: 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 requirements.
Now Requirements Qualifications section: "Basic Qualification Requirements: This Investigator job family covers professional positions that conduct inspections..." Actually that seems overlapping with duties. But we have separate "Basic Qualification Requirements:" paragraph that describes the job family. Might be considered part of requirements.
Then "Education and/or Experience Requirement:" with bullet options.
We need to capture that.
Also note: "NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications." That's a requirement.
Also motivational paragraphs: "Become a part of the Department that touches the lives of every American..." etc. That's more about the agency; could be "About the role" or maybe we can include in "About the role". But we should not include boilerplate like EEO etc. This is motivational but still substantive? It's about HHS mission. Might be considered part of "About the role". We'll include.
Also description of OII: "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's substantive.
Now we need to decide sections.
Potential sections:
- About the role: includes hiring authority, appointment type, pay table, location, agency description, OII description, motivational HHS mission.
- Responsibilities: list of duties (as above).
- Requirements: includes basic qualification requirements description (job family) and note about transcripts.
- Qualifications: education/experience requirements (the four options) plus knowledge of scientific fields.
We should not create Skills section unless present; not present.
We should not create Benefits, Pay, Schedule unless present; we have pay table info but that's about pay band; but the instruction says never create Pay/Schedule/Benefits sections unless the posting actually states them. It does state pay table: "This position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent)." That is pay info. Should we include a Pay section? The instruction: "never create Pay/Schedule/Benefits sections unless the posting actually states them." It does state pay table, so we could include a Pay section. However they also said "Prefer a few substantive sections over many thin ones." Could embed pay info in About the role. But they said include a section ONLY when posting has real, specific content for it. The pay table is specific content. So we could either include a Pay section or include it in About the role. The instruction: "Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So they expect those as possible headings. If we include Pay, we must have real content. We have that. So we could add a Pay section with that line. Similarly, Schedule not present, Benefits not present. Thus sections: About the role, Responsibilities, Requirements, Qualifications, Pay. We must avoid duplication. Ensure we don't repeat same info in multiple sections. Let's craft. About the role: include hiring authority, appointment type, location (DHHS, FDA, OII, OIO), OII description, HHS mission motivational paragraph. Responsibilities: bullet list of duties (the long list). Also maybe include the objective statement about preventing unsafe products etc. Could be part of duties. Requirements: basic qualification requirements description (the paragraph that starts "This Investigator job family covers professional positions...") plus note about transcripts. Qualifications: education/experience requirements (the four options) plus knowledge of scientific fields list. Pay: mention Title 21 Pay Table 1, Band B (GS-12 equivalent). We need to ensure we preserve all substantive information: also mention that candidate will be paid under provisions of this authority (already in About the role). Also mention career or career-conditional appointment. Also mention that the position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent). Already in Pay. Also mention that the position is located in DHHS, FDA, OII, OIO. Also mention OII professionals work in range of program areas and locations, with 196 offices throughout US. Also mention that the position investigates and/or inspects FDA-regulated industry globally etc. Also mention that investigators 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 list. Also mention that the 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. Also mention that the candidate selected will serve under a career or career-conditional appointment and be paid under the provisions of this authority. Also mention that the position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent). Already. Also mention that the position is being recruited based on the Title 21 Pay Table 1, Band B (GS-12 equivalent). Already. Also mention that the position is being recruited based on the Title 21 Pay Table 1, Band