Arrowhead Pharmaceuticals · 15 hours ago
Specialist II, Internal Quality Assurance (temp to hire)
Verona, Wisconsin, United States
Full-time
Onsite
Mid Level
$70K/yr - $85K/yr
3+ years expArrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing innovative drugs for diseases with a genetic basis. The Specialist II in Internal Quality Assurance will support ongoing development programs for drug candidates by reviewing manufacturing batch records, analytical data, and ensuring compliance with Good Manufacturing Practices (cGMP).
BiotechnologyHealth CareNanotechnologyPharmaceutical
No H1B
Responsibilities
Interact with representatives from other departments, including manufacturing, QC, and Analytical Development, to obtain the necessary information for review of documentation
Review and approve analytical testing data and final reports from internal and external sources with minimal supervision
Review and approve manufacturing batch records, forms, and associated testing with minimal supervision
Perform room releases as required
Perform QA on the floor as required
Assist with investigations and deviations as appropriate with minimal supervision
Organization and control of project related documentation
Issue, review, and reconcile controlled forms
Review, verify, and reconcile labels
Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval
Maintain knowledge of current compliance expectations and regulations pertaining to drug development
Assist with Good Documentation Practices, GMP, and data integrity training as needed
Additional duties as assigned
Qualification
Required
BS/BA in Chemistry, Biology, Biochemistry, or related scientific field is preferred
3 years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical manufacturing environment
Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents
Preferred
Experience with quality systems supporting GMP regulations (21 CFR Parts 11, 210, 211, and EU GMP, including Annex 11 and 15)
Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet
Prior experience with use of an electronic document management system in a regulated environment
Benefits
Competitive salaries
Excellent benefit package
Company
Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals is a biotechnology company that focuses on the development of medicine to treat diseases with a genetic origin.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.45BKey Investors
Sarepta TherapeuticsSixth StreetSilence Therapeutics
2026-01-07Post Ipo Equity· $200M
2026-01-07Post Ipo Debt· $625M
2024-11-26Post Ipo Equity· $325M
Leadership Team
Christopher Anzalone
President and Chief Executive Officer
Recent News
2026-01-14
Company data provided by crunchbase