The Position 

This position will assist Quality Assurance with compliance activities at Arrowhead Pharmaceuticals. The incumbent will track training for employees, as appropriate., as well as keep updated training documentation for all staff within Arrowhead’s quality systems under the direction of QA management. The incumbent may also assist with document control by drafting new procedures, updating existing documents within Arrowhead’s quality systems, issuing controlled documentation, and maintaining archival of completed documentation.

Responsibilities 

• Manage employee’s training files and job descriptions within Arrowhead’s EDMS
• Issue controlled forms, notebooks, etc
• Assist with preparation, update, review, and routing of Arrowhead procedural documents
• Assist QA management with the implementation and upkeep of a LMS (Learning Management System), including development and management of training curricula, driving consistency across departments, and ensuring access to proper leaning materials
• Track and report on training compliance; notify management of over-due employee training requirements
• Interact with personnel companywide to obtain the necessary information and details for preparing training records
• Upload documents to Arrowhead’s EDMS, Veeva QualityDocs, and route for electronic approval
• Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval
• Manage and ensure timely review of periodic review assignment within the EDMS
• Write standard operating procedures and work instructions as needed for all types of quality systems and practices
• Assist with Veeva and other system implementations
• Assist with QA duties as needed

Requirements:

• Minimum of an Associate degree in applicable science field
• Preferred experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization writing and maintaining documents
• Working knowledge of GMP, GCP, and/or GLP regulations
• Competent knowledge of, and ability to use and format within Adobe Acrobat and Microsoft Office

Preferred: 

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
• 3 years of experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization writing and maintaining documents
• Prior experience with use of an electronic document management system in a regulated environment