Senior Quality Specialist, CAPA Investigations

The user wants me to reformat a job posting into clean, well-structured semantic HTML. I need to follow specific rules: 1. Use

for section headings (About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule) 2. Use

• for lists of duties/requirements/benefits, and

  for prose 3. Do NOT repeat the job title as a heading 4. Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

  or drop it 5. Preserve ALL substantive information; do NOT invent or summarize away detail 6. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions 7. Include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text 8. Never create Pay/Schedule/Benefits sections unless the posting actually states them 9. Prefer a few substantive sections over many thin ones 10. Output ONLY the HTML fragment — no /, no markdown code fences Let me analyze the job posting: The posting starts with company description (Arrowhead Pharmaceuticals), then "The Position" section describing the role, then "Responsibilities" with subsections (CAPA and Investigation Execution, Communication, Metrics, and Governance, Training, Systems, and Inspection Support, Cross-Functional Collaboration and Compliance), then "Requirements" with a list, then "Preferred" with a list, then pay range for Wisconsin, then mention of competitive salaries and benefit package, then authorization requirement, then California Applicant Privacy Policy. I need to structure this into semantic HTML. The job title isn't explicitly given but it's implied to be a CAPA-related senior role. The user said not to repeat the job title as a heading. I should create sections for: - About the role (from "The Position" paragraph) - Responsibilities (with subsections as lists) - Requirements (the Requirements list) - Preferred Qualifications (the Preferred list) - Pay (since Wisconsin pay range is given) - Benefits (mentioned "excellent benefit package" but no details - should I include? The rule says never create Benefits section unless posting actually states them. It says "Arrowhead provides competitive salaries and an excellent benefit package." That's a statement but no details. I think I should include a brief mention in a Pay section or separate Benefits section? The rule says "never create Pay/Schedule/Benefits sections unless the posting actually states them." It states "excellent benefit package" but no details. I'll include a brief Benefits section with that statement, or maybe fold into Pay section. I'll create a Pay section with the Wisconsin range and mention of competitive salaries and benefits. Also need to remove boilerplate: California Applicant Privacy Policy, authorization requirement (maybe keep as a note?), but the rule says remove legal/EEO/equal-opportunity/scam-warning boilerplate. Authorization requirement might be considered legal boilerplate. I'll drop it. Also remove duplicated lines. Let me structure:

  About the role

  ...The Position paragraph...

  Responsibilities

  Then for each subsection, I could use

  ? But the rule says use

  for section headings. It doesn't mention subheadings. I could use

  for subsections, but the rule only specifies

  for section headings. I think I should use

  for main sections only, and for subsections maybe use or just list items grouped. However, the responsibilities have clear subsections: CAPA and Investigation Execution, Communication, Metrics, and Governance, Training, Systems, and Inspection Support, Cross-Functional Collaboration and Compliance. I could make each a

  but the rule doesn't forbid other heading levels. It says "use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It doesn't say not to use other headings. But to be safe, I'll keep only

  for main sections, and for subsections I'll use labels within list items or separate paragraphs. Better: For Responsibilities, I'll create a

  with each responsibility as a list item, but they are grouped. I could create nested lists: each subsection as a list item with a nested list of duties. That would preserve structure. Let me parse responsibilities: CAPA and Investigation Execution: - Participate in or lead CAPA projects... - Lead investigation into quality events... - Partner with subject matter experts... - Establish appropriate CAPA ownership... - Process CAPA requests... - Assess final supporting documentation... - Communicate CAPA and investigation metrics... (wait that's under Communication) Actually the subsections are separate. I'll create a list for each subsection, but under a single Responsibilities section. I'll use

  Responsibilities

  then for each subsection, a

  ? The rule doesn't forbid

  . But the instruction says "use

  for section headings". It doesn't say "only use

  ". I think using

  for subsections is fine. However, to be safe, I'll use for subsection titles and then

  for each. Let me decide: I'll output:

  About the role

  ...

  Responsibilities

  CAPA and Investigation Execution

  • ...
  ...

  Communication, Metrics, and Governance

  • ...
  ...

  Training, Systems, and Inspection Support

  • ...
  ...

  Cross-Functional Collaboration and Compliance

  • ...
  ...
  But the rule says "use

  for section headings". It doesn't mention

  . I think it's acceptable. Alternatively, I could make each subsection a separate

  but that would be too many sections. The rule says "Prefer a few substantive sections over many thin ones." So keep Responsibilities as one section with subsections. I'll use

  for subsections. Now Requirements: list of requirements. I'll make

  Requirements

  then
  • ...
  Preferred:

  Preferred Qualifications

  then
  • ...
  Pay:

  Pay

  with

  Wisconsin pay range: $90,000 - $110,000 USD. Arrowhead provides competitive salaries and an excellent benefit package.

  Benefits: The posting says "excellent benefit package" but no details. I could include a Benefits section with that statement, but the rule says never create Benefits section unless posting actually states them. It states "excellent benefit package" but no specifics. I'll include a brief Benefits section with that phrase, or fold into Pay. I'll create a Benefits section with a single

  stating "Arrowhead provides an excellent benefit package." That's substantive enough? It's a statement but no details. The rule says "never emit a heading followed by filler/placeholder text". This is not filler, it's a direct quote. I'll include it. Schedule: Not mentioned, so no Schedule section. Also need to remove California Applicant Privacy Policy and authorization requirement. Now, the company description at the beginning: Should I include? The user said "reformat a job posting into clean, well-structured semantic HTML." The company description is part of the posting. I could include an "About the company" section, but the rule says use

  for section headings like "About the role". It doesn't mention "About the company". But I can include it as a section. However, the rule says "Do NOT repeat the job title as a heading (the page already shows it)". The company description is not the job title. I think I should include it as a section, maybe "About Arrowhead Pharmaceuticals". But the rule says "Prefer a few substantive sections over many thin ones." The company description is substantive. I'll include it as

  About Arrowhead Pharmaceuticals

  with paragraphs. But the user might expect only job-specific sections. The instruction says "reformat a job posting". The posting includes company description. I'll include it. Let me structure:

  About Arrowhead Pharmaceuticals

  Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

  Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

  Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

  About the role

  Serve as a senior contributor to the Corrective and Preventive Action (CAPA) program within the Quality Management System (QMS), facilitating and executing CAPA and investigation activities to support ongoing development and commercial programs at Arrowhead. Provide oversight of CAPA record processing, root cause analysis, and effectiveness checks to ensure timely, compliant, and quality-driven resolution of quality events. Partner with cross-functional teams and subject matter experts to ensure root causes are thoroughly investigated, corrective and preventive actions are appropriately implemented, and CAPAs are closed in alignment with regulatory requirements and quality goals.

  Responsibilities

  CAPA and Investigation Execution

  • Participate in or lead CAPA projects, ensuring records are completed with appropriate quality, compliance, and timeliness.
  • Lead investigation into quality events, gather relevant data, and perform preliminary root cause analysis using structured problem-solving methodologies, such as Six Sigma, 5 Whys, and fishbone analysis.
  • Partner with subject matter experts to ensure root causes are thoroughly investigated, product impact to Safety, Identity, Strength, Purity, and Quality (SISPQ) is assessed, and appropriate corrective and preventive actions are identified.
  • Establish appropriate CAPA ownership and timelines based on the risk associated with the event or issue.
  • Process CAPA requests by assigning owners and supporting timely responses and approvals in alignment with quality goals.
  • Assess final supporting documentation for adequacy prior to CAPA closure and conduct effectiveness checks for high-risk CAPAs.

  Communication, Metrics, and Governance

  • Coordinate and support CAPA Quality Review Board (QRB) meetings, including agenda preparation, meeting minutes, and tracking follow-up action items to closure.
  • Communicate CAPA and investigation metrics, trends, and escalations to management and