Quality Assurance Specialist II - Internal Quality

Arrowhead Pharmaceuticals; Madison (WI); Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a Quality Assurance Specialist II to support ongoing development programs for preclinical, clinical, and commercial drug candidates.

The role focuses on reviewing manufacturing batch records, analytical data, and related documents to ensure cGMP compliance and data integrity. The position requires a BS/BA in a scientific field, 3+ years of QA experience in biotech/pharma, strong communication, and organizational skills.

Qualifications

• BS/BA in a scientific field such as chemistry, biology, or biochemistry.
• Minimum 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.

Responsibilities

• Interact with representatives from other departments to obtain information for review of documentation.
• Review and approve analytical testing data and final reports from internal and external sources with minimal supervision.
• Review and approve manufacturing batch records, forms, and associated testing with minimal supervision.
• Review and approve internally generated raw material data and documentation with minimal supervision.
• Perform lot disposition and release of raw materials with minimal supervision.
• Perform room releases as required.
• Perform QA on the floor as required.
• Assist with investigations and deviations as appropriate with minimal supervision.
• Organization and control of project related documentation.
• Issue, review, and reconcile controlled forms.
• Review, verify, and reconcile labels.
• Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval.
• Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
• Assist with Good Documentation Practices, GMP, and data integrity training as needed.
• Additional duties as assigned.

Skills

Communication skills

Attention to detail

Independent work

Prioritization

Documentation

Education

BS/BA in science

Tools

Microsoft Word

Excel

Smartsheet

EDMS

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 within the Quality Assurance department is to support on-going development programs for preclinical, clinical, and commercial drug candidates at Arrowhead. Key functions of this position may involve review of manufacturing batch records, analytical data and reports, associated documents and other activities needed to support operations within the Quality Assurance department and will also support general quality systems related to current Good Manufacturing Practices (cGMP) within the organization. The Specialist II is expected to interact with multiple internal departments.

Responsibilities

• Interact with representatives from other departments, including manufacturing, QC, and Analytical Development, to obtain the necessary information for review of documentation.
• Review and approve analytical testing data and final reports from internal and external sources with minimal supervision.
• Review and approve manufacturing batch records, forms, and associated testing with minimal supervision.
• Review and approve internally generated raw material data and documentation with minimal supervision.
• Perform lot disposition and release of raw materials with minimal supervision.
• Perform room releases as required.
• Perform QA on the floor as required.
• Assist with investigations and deviations as appropriate with minimal supervision.
• Organization and control of project related documentation.
• Issue, review, and reconcile controlled forms.
• Review, verify, and reconcile labels.
• Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval.
• Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
• Assist with Good Documentation Practices, GMP, and data integrity training as needed.
• Additional duties as assigned.

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

• 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

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.