Archivist - Higher Ed. jobs in Wisconsin

The Position

The Quality Assurance Archivist will ensure proper storage, retrieval, and eventual destruction of documentation generated during execution of studies pertaining to Arrowhead's clinical candidates. The focus will be on GxP related data and documentation but may also include non-GxP study materials. The incumbent will also participate in general quality assurance documentation management activities and assist with maintaining Arrowhead's electronic document management system (EMDS) – Veeva QualityDocs.

Responsibilities

• Manage external archiving vendors and ensure proper conditions exist and are maintained
• Ensure that all electronic and paper raw data, documentation, protocols (including amendments & deviations), final reports and samples collected from the study are retained in accordance with the approved protocol and GxP regulation
• Ensure that the archive system allows for orderly storage and expedient retrieval of all raw data, documentation, protocols, samples and final reports
• Ensure that materials retained in archives are appropriately indexed to permit expedient retrieval.
• Coordinates transfer of materials and data records as needed
• Maintain an index for archived CFR-compliant records, perform data entry and ensure accuracy and quality of database
• Communicate with CRO/CMO regarding proper shipping/handling of records/documentation being sent to Arrowhead, or Arrowhead's external storage facility, for archiving
• Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval
• Organize qualification/validation documentation and upload final electronic versions to EDMS
• Maintain internal SOPs/Work Instructions regarding document archiving and retention
• Organize and maintain an internal GxP document storage/records room
• Support Operations/Facilities with maintaining final version of facility and equipment drawings; ensure redlines or revisions are incorporated into updated official drawing sets
• Additional duties as assigned

Requirements:

• High School diploma
• At least three years of experience working in a FDA regulated environment in an archiving or document management role
• Working knowledge of Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and/or Good Documentation Practices (GDP) regulations pertaining to document archiving requirements
• Competent knowledge of and ability to use Microsoft Word and Excel
• Ability to follow company procedures, work instructions, and policies
• 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

Preferred:

• An Associate's or Bachelor's degree in a related field is preferred, but not required
• Prior experience with use of an electronic document management system in a regulated environment