Quality Assurance Specialist II - External Quality

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI seeks a Quality Assurance professional to support development, clinical, and commercial programs.

You will review vendor documentation, perform lot disposition, and generate certificates of compliance while coordinating with internal teams and contract organizations. The role requires a BS/BA in a scientific field, 3+ years in biotech QA, and strong knowledge of GMP/GCP/GLP and ICH/FDA guidance.

Qualifications

• BS/BA in chemistry, biology, or biochemistry.
• 3+ years in QA in biotech/pharma development or contract manufacturing.
• Knowledge of GMP, GCP, GLP, ICH and FDA guidance.
• Excellent communication and organizational skills.
• Ability to work independently in a fast-paced environment.

Responsibilities

• Provide QA support for development, clinical, and commercial programs.
• Review and approve vendor documentation (CoA, batch records, labels, reports).
• Collaborate with vendors on quality events and non-conformances.
• Perform lot disposition and issue certificates of compliance.
• Assist with QA duties and procedure document control.
• Manage EDMS document uploading and routing.

Skills

Quality Assurance

Communication skills

Attention to detail

Independent work

Education

BS/BA in chemistry/biology/biochemistry

Tools

EDMS

Adobe Acrobat

Microsoft Office

Smartsheet

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial 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 is to provide quality assurance support to programs utilizing contract development, manufacturing, and testing organizations. The incumbent will review vendor documentation and perform lot disposition per applicable quality agreements as well as capture quality data and generate metrics for vendors. The incumbent will be expected to interact with internal departments as well as multiple contract organizations to support ongoing commercial, pre-clinical and clinical development programs at Arrowhead Pharmaceuticals, Inc.

Responsibilities

• Interact with personnel companywide to obtain the necessary information and details to provide quality assurance support of development, clinical, and commercial programs.
• Review and approve vendor generated documentation, including but not limited to, executed batch records, testing records, certificates of analysis (CoA), labels, protocols, and reports.
• Collaborate with vendors on quality events and non-conformances as outlined in the applicable quality agreement.
• Perform lot disposition and generate certificates of compliance (CoC) as necessary.
• Assist with preparation, update, review, and routing of Arrowhead procedural documents.
• Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval.
• Assist with QA duties as needed.

Requirements

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
• Minimum of 3 years of quality assurance or similar 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.
• 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 fast-paced environment.

Preferred

• Prior experience with use of an electronic document management system in a regulated environment is preferred.
• Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, and Smartsheet.

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.