Senior Specialist, Quality Assurance (2nd Shift) at Arrowhead Pharmaceuticals

Verona, Wisconsin, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Dec, 25

Salary

110000.0

Posted On

20 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Good Manufacturing Practices, Documentation Control, Communication Skills, Team Collaboration, Problem Solving, Regulatory Compliance, Detail Oriented, Self-Starter, GMP Regulations, Analytical Development, Project Management, Quality Control, Change Control, Internal Quality Events, Documentation Management

Industry

Biotechnology Research

Description

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. 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. 2nd shift work hours are ~1pm – 11:30pm and includes a 10% shift differential. 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. Requirements: Bachelor's degree in a science discipline, or equivalent required. 8 years of experience working in a regulated environment with preference to quality assurance and/or manufacturing experience 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. 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. Wisconsin pay range $90,000—$110,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Responsibilities

The Senior Specialist in Quality Assurance will support ongoing development programs for drug candidates and maintain quality systems in compliance with GMP. This role involves reviewing documentation, performing QA on the manufacturing floor, and collaborating with various internal departments.