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Specialist II, Internal Quality Assurance

Arrowhead Pharmaceuticals, Inc

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Location:
United States , Verona

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Contract Type:
Employment contract

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Salary:

70000.00 - 85000.00 USD / Year

Job Description:

The purpose of this position within the Quality Assurance department is to support on-going development programs for preclinical, clinical, and commercial drug candidates at Arrowhead. A key function of the position will involve review of manufacturing batch records, analytical data and reports, and associated documents within the Quality Assurance department and will also support general quality systems related to current Good Manufacturing Practices (cGMP) within the organization. The Specialist II is expected to interact with multiple internal departments.

Job Responsibility:

  • 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

Requirements:

  • 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

Nice to have:

  • 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
What we offer:

competitive salaries and an excellent benefit package

Additional Information:

Job Posted:
February 10, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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