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Sr. Quality Assurance Specialist

Company: Arrowhead Pharmaceuticals
Location: Madison
Posted on: May 16, 2022

Job Description:

The Position

The purpose of this position within the Quality Assurance department is to support on-going development programs for preclinical and clinical drug candidates at Arrowhead. A key function of the position will involve continued development and maintenance of quality systems supporting Good Manufacturing Practices (GMP) within the organization. The candidate will be expected to interact with multiple internal departments, as well as assist with quality oversight functions for external organizations.


Contribute to the development of quality and compliance systems to support pre-clinical and clinical phase drug development
Writing, review, change control, approval, issuance, and organization of Standard Operating Procedures (SOPs)
Organization and control of quality, compliance, and project related documentation
Support utilization of an electronic document management system (Veeva QualityDocs)
Review and approval of internal and vendor generated documentation
Perform Quality related tasks in coordination with Manufacturing and Finance
Issuance, review, tracking, and completion of internal deviations, out of specifications, and CAPAs
Auditing of vendor and internal documentation and files
Assisting with generation, tracking, monitoring, and reporting of key quality metrics
Maintain knowledge of current compliance expectations and regulations pertaining to drug development
Collaborate with, and provide quality support for, other departments (Manufacturing, QC, Project Management, Toxicology, Clinical Operations, etc.)
Participate in meetings with vendors and external organizations as the QA team representative
Other duties consistent with the position as assigned from time to time


Minimum of 8 years of experience in a pharmaceutical development company and/or contract manufacturing organization
Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents
Prior experience with use of an electronic document management system in a regulated environment
Understanding of document control requirements in a FDA regulated organization
Competent knowledge of and ability to use Microsoft Word and Excel
Ability for occasional business travel
Excellent written and verbal communication skills and ability to communicate with internal and external parties
Ability to work with diverse professionals and promote cooperation, shared understanding, and commitment to ensuring best in class quality assurance protocols
Highly motivated team player willing to contribute to a growing pharmaceutical organization
Ability to work independently with minimal supervision and as well as manage priorities within a fastpaced environment
A detail oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities at Arrowhead


Previous experience with quality systems supporting drug-device combination products per 21 CFR Part 3 and medical devices QSR per 21 CFR Part 820/ISO 13485

Keywords: Arrowhead Pharmaceuticals, Madison , Sr. Quality Assurance Specialist, Other , Madison, Wisconsin

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