Lead, Documentation Specialist
Arrowhead Pharmaceuticals, Verona, Wisconsin, United States, 53593
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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.
The Position This position will be primarily responsible for drafting, editing, and standardizing GMP documentation for deviations, investigations, CAPAs, and change controls. Ensures records are clear, compliant, complete, and inspection-ready, aligning to site procedures, data integrity expectations, and applicable regulations. Partners with SMEs and cross-functional owners to translate technical content into high-quality QMS records with consistent structure and strong rationale.
Responsibilities
Draft and edit deviations and investigation narratives (event description, timeline, impact, conclusions).
Convert SME input into clear root cause documentation aligned to evidence.
Write CAPAs linked to root cause, including action plans and effectiveness checks.
Draft change controls (rationale, scope, impacted areas/docs, implementation plan).
Ensure records are complete, consistent, and inspection-ready (traceability, attachments, objective evidence).
Apply site procedures and data integrity / cGMP expectations in all Manufacturing QMS records.
Coordinate with cross-functional owners to improve first-pass approvals and ensure thorough investigations.
Support audits/inspections by quickly clarifying or revising QMS narratives as needed.
Requirements
BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
3 years working in a GMP setting with a minimum of 2 years of experience authoring change controls and/or investigating deviations.
Proficient experience working with controlled documentation
Experience with internal CAPA investigations
Ability to collaborate with and coordinate cross-functional teams
Proficiency with Microsoft Suite applications (Word, Excel)
High attention to detail
Ability to multi-task and manage responsibilities within ongoing projects
Preferred
5+ year's GMP experience and 3+ cGMP deviation and/or change control experience
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
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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.
The Position This position will be primarily responsible for drafting, editing, and standardizing GMP documentation for deviations, investigations, CAPAs, and change controls. Ensures records are clear, compliant, complete, and inspection-ready, aligning to site procedures, data integrity expectations, and applicable regulations. Partners with SMEs and cross-functional owners to translate technical content into high-quality QMS records with consistent structure and strong rationale.
Responsibilities
Draft and edit deviations and investigation narratives (event description, timeline, impact, conclusions).
Convert SME input into clear root cause documentation aligned to evidence.
Write CAPAs linked to root cause, including action plans and effectiveness checks.
Draft change controls (rationale, scope, impacted areas/docs, implementation plan).
Ensure records are complete, consistent, and inspection-ready (traceability, attachments, objective evidence).
Apply site procedures and data integrity / cGMP expectations in all Manufacturing QMS records.
Coordinate with cross-functional owners to improve first-pass approvals and ensure thorough investigations.
Support audits/inspections by quickly clarifying or revising QMS narratives as needed.
Requirements
BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
3 years working in a GMP setting with a minimum of 2 years of experience authoring change controls and/or investigating deviations.
Proficient experience working with controlled documentation
Experience with internal CAPA investigations
Ability to collaborate with and coordinate cross-functional teams
Proficiency with Microsoft Suite applications (Word, Excel)
High attention to detail
Ability to multi-task and manage responsibilities within ongoing projects
Preferred
5+ year's GMP experience and 3+ cGMP deviation and/or change control experience
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
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