The Position This position within the Quality Assurance department will support ongoing programs for commercialization at Arrowhead. A key function of the position will involve providing leadership and guidance in principles of analytical method verification/validation in support of pre-clinical/clinical and commercialization activities at Arrowhead.
Generally, the position will support continued development and maintenance of quality systems supporting Good Manufacturing Practices (GMP) within the organization. Functions of this position will include serving as the Quality Assurance subject matter expert in method verification/validation, cross-functional interaction with internal departments to establish and/or update associated procedures/processes, review/approval of method validation documentation, performing validation assessment of changes and deviations for test methods used for GMP manufacturing.
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.
Requirements- A bachelor's degree, or higher, in a science field.
- Bachelor's degree with 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.
Wisconsin pay range
$95,000-$125,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
