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
- Proficient project management skills
- 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.
Wisconsin pay range
$85,000-$98,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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