Quality Assurance Engineer - Method Validation & GMP

Doist; Verona (WI); On-site; USD 95,000 - 125,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Wisconsin is seeking a Quality Assurance expert in method validation to support commercialization activities. The role includes leading validation strategy, ensuring data integrity, and maintaining GMP compliance across development and manufacturing.

You will mentor QA staff, collaborate with cross-functional teams, review validation documentation, and support internal/external audits. Competitive salary and benefits are offered.

Qualifications

• A bachelor’s degree, or higher, in a science field.
• 8+ years of experience working within cGMP-regulated manufacturing, specifically in method validation-related roles in manufacturing and/or quality.
• Working knowledge of GMP regulations (ICH Q2, ICH Q7, 21CFR Part 210/211, EU Annex 11/15, and 21CFR Part 11).
• Excellent attention to detail and organizational skills.
• Ability to multi-task and prioritize work tasks with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.
• Competent knowledge and ability to use Microsoft Word and Excel.
• Preferred: Prior experience with the use of an electronic document management system in a regulated environment is preferred.
• Candidates must have current, valid authorization to work in the country where this role is located.

Responsibilities

• Serve as the Quality Assurance subject matter expert on method validation. This includes providing guidance, review, and/or approval of applicable validation strategy for analytical methods and supporting validation documentation.
• This position will also serve as a data reviewer, ensuring adherence to good documentation practices and data integrity.
• Draft, review, and approve procedures in support of quality systems for qualification and validation.
• Serve as a resource to mentor Quality Assurance members in Quality Engineering functions (e.g., department procedures, audits, method validation, validation assessments, etc.).
• Work with cross-functional teams in the review and approval of internal and vendor-generated data/documentation in support of validation, qualification, and commissioning activities.
• Provide guidance on suitability of applicable equipment and assessment for use for validated method execution.
• Prepare documentation and provide support for internal and external audits.
• Provide support for the issuance, review, tracking, and approval of internal deviations, change controls, and CAPAs as related to validation activities and assessments.
• Support the development and implementation of periodic reviews for validated systems/processes including establishment of CPV procedures for commercial manufacturing.
• Other duties, consistent with the position, as assigned.

Skills

Quality Assurance

Method Validation

Data Integrity

Documentation

Education

Bachelor's degree in science

Tools

Microsoft Word

Microsoft Excel

Job description

Arrowhead Pharmaceuticals, Inc. in Wisconsin is seeking a Quality Assurance expert in method validation to support commercialization activities. The role includes leading validation strategy, ensuring data integrity, and maintaining GMP compliance across development and manufacturing.

You will mentor QA staff, collaborate with cross-functional teams, review validation documentation, and support internal/external audits. Competitive salary and benefits are offered.