Senior Specialist, Quality Assurance (2nd Shift)

Arrowhead Pharmaceuticals•Verona, WI

5d•Onsite

About The Position

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 continued development and maintenance of quality systems supporting Good Manufacturing Practices (GMP) within the organization. The Senior Specialist is expected to interact with multiple internal departments, as well as assist with quality oversight functions for external organizations.

Requirements

Minimum of a bachelor's degree in a science discipline, or equivalent required.
Minimum of eight (8) years of experience working in a regulated environment with preference to quality assurance and/or manufacturing experience or equivalent required.
Excellent written and verbal communication skills and ability to communicate effectively 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 and manage priorities within a fast-paced environment.
A detail-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities at Arrowhead.
Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents.
Understanding of document control requirements in an FDA regulated organization.
Ability for occasional business travel.

Nice To Haves

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.

Responsibilities

Review and approval of internal and vendor generated documentation, including master batch records, executed batch records, labels, certificates, reports, and testing records.
Perform QA on the floor and manufacturing room release.
Review and release of completed manufacturing batch documentation including Quality Control (QC) and Analytical Development (AD) data and issuance of Certificates of Analysis.
Writing, review, change control, approval, issuance, and organization of applicable procedural documents.
Issuance, review, tracking, and completion of internal quality events (QEs), such as deviations, out of specifications (OOS), and CAPAs.
Organization and control of quality, compliance, and project related documentation.
Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
Collaborate with, and provide quality support for, other departments (Manufacturing, QC, AD, Project Management, etc.).
Participate in meetings as the QA team representative as needed.
Additional duties as assigned.