Senior Quality Assurance Specialist

Arrowhead Pharmaceuticals, Inc; Verona (WI); On-site; USD 85,000 - 115,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking a Senior Quality Assurance Specialist to ensure compliance and quality in supplier documentation processes. This role supports ongoing clinical and commercial programs and requires a deep understanding of regulatory guidelines, along with strong interpersonal and organizational skills. The successful candidate will have at least 8 years of experience in quality assurance within the biopharma industry.

Benefits

Competitive salaries

Excellent benefit package

Qualifications

• Minimum 8 years in quality assurance in biotech/pharma.
• Knowledge of GMP, GCP, GLP regulations.
• Experience with electronic document management systems.

Responsibilities

• Manage supplier documentation for compliance.
• Oversee quality agreement lifecycle management.
• Collaborate on quality events and non-conformance.

Skills

Communication

Attention to Detail

Organizational Skills

Interpersonal Skills

Education

BS/BA in a scientific field

Tools

Adobe Acrobat

Microsoft Office

DocuSign

SmartSheet

Job description

Senior Quality Assurance Specialist (Supplier Quality)

Senior Quality Assurance Specialist (Supplier Quality)

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 and San Diego, CA. 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 is to provide quality assurance support to programs utilizing contract development, manufacturing, and testing organizations. This role is part of a team that oversees all aspects of supplier quality. This person will be expected to interact with contract organizations as well as internal departments to support ongoing pre-clinical and clinical development as well as commercial programs at Arrowhead Pharmaceuticals, Inc.

Responsibilities

• Complete requests for supplier documentation in support of supplier maintenance activities.
• Perform quality agreement lifecycle management, including but not limited to, drafting, editing, reviewing, approving, and ensuring compliance with periodic review cycles.
• Review, approve, categorize, and maintain supplier documentation, including but not limited to, questionnaires, registration documents, accreditations, certifications, BSE/TSE statements, etc.
• Collaborate with QA teammates and supplier quality assurance representatives on supplier quality events and non-conformances as outlined in the applicable quality agreements.
• Capture supplier quality data and generate metrics.
• Scan and upload documents to the EDMS, properly categorize within the system, and route for verification/approval.
• Assist with preparation, update, review, and routing of Arrowhead procedural documents.
• Assist with QA duties as needed.

Requirements:

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred
• 8 years of quality assurance experience in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization.
• Working knowledge of GMP, GCP, and/or GLP regulations as well as ICH and FDA guidance documents.
• Prior experience with use of an electronic document management system in a regulated environment.
• Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, DocuSign, and SmartSheet.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to consistently communicate with external parties in a professional manner.
• Ability to follow company procedures, work instructions, and policies.
• Excellent attention to detail and organizational skills.
• Ability to work independently with minimal supervision as well as manage priorities within a face paced environment.

$85,000 — $115,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

The job you are looking for is no longer open.

Current openings at Arrowhead Pharmaceuticals