Specialist III, Quality Assurance (External Quality)

Arrowhead Pharmaceuticals; Verona (WI); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Competitive salaries

Excellent benefit package

Job summary

A biopharmaceutical company in Verona, Wisconsin is seeking a Quality Assurance professional to provide support for development and clinical programs. The ideal candidate will have at least 5 years of experience in a GMP-regulated environment and hold a BS/BA in a scientific field. Responsibilities include reviewing vendor documentation, collaborating with internal departments, and ensuring compliance with quality standards. Excellent communication skills are essential as you will work closely with multiple organizations to maintain quality assurance in the clinical pipeline.

Qualifications

• 5 years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical manufacturing environment.
• Working knowledge of drug GMP regulations and ICH/FDA guidance documents.
• Ability to manage priorities in a fast-paced environment with minimal supervision.
• Ability to manage priorities within a fast-paced environment with minimal supervision.
• Excellent written and verbal communication skills.

Responsibilities

• Provide quality assurance support for development, clinical, and commercial programs.
• Review and approve vendor-generated documentation.
• Collaborate with vendors on quality events and non-conformances.
• Perform lot disposition and generate certificates of compliance as needed.
• Assist with tracking vendor quality metrics and QA documentation routing.

Skills

Quality Assurance

GMP regulations

Communication

Document management

Vendor interaction

Education

BS/BA in Chemistry, Biology, Biochemistry, or related field

Tools

Adobe Acrobat

Microsoft Office

SmartSheet

Job 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 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 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, master and 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 tracking vendor quality metrics; notify QA management of any performance issues.
• 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.
• Draft, review, and approve standard operating procedures (SOP) and work instructions (WI) as needed.
• Assist with QA duties as needed.

Requirements

• BS/BA in Chemistry, Biology, Biochemistry, or related scientific field is preferred.
• 5 years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical manufacturing environment
• Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents.
• Ability to manage priorities within a fast-paced environment with minimal supervision.
• Excellent written and verbal communication skills and ability to communicate effectively with internal and external parties.

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.

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