Arrowhead Pharmaceuticals, Inc. needs to provide quality assurance support to programs utilizing contract development, manufacturing, and testing organizations.
Requirements
- Working knowledge of GMP, GCP, and/or GLP regulations as well as ICH and FDA guidance documents.
- 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.
Responsibilities
- Review vendor documentation and perform lot disposition per applicable quality agreements as well as capture quality data and generate metrics for vendors.
- 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 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.
Other
- 3 years of quality assurance experience in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization.
- 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 face paced environment.
- All applicants must have authorization to work in the US for a company.
