Responsible for digital and hard-copy archival of quality documents including Device History Records (DHR's). Verify legibility of digitized scans and coordinate off-site storage of documentation. Work with minimal supervision and a demonstrated ability of independent action following established practices and procedures.
Principal Duties and Responsibilities
* Scan incoming quality records.
* Coordinate storage of hard copy archived documents both on and off-site.
* File documentation in appropriate locations.
* Enter metadata for scanned documents.
* Assist various departments with document retrieval as needed.
* Provide user training of archival system as needed.
Expected Areas of Competence
* Ability to use the following equipment: personal computer, scanner, printer, and copier.
* Familiar with various software applications including word processing, spreadsheets, web-based repositories, and Adobe Acrobat.
* Knowledge of GMP and ISO requirements for the Document Control Section.
* Must have good communications and interpersonal skills.
* Must be able to read, write and understand English.
* Ability to work both independently and in a team environment.
* Cross-train to support Document Control and LMS Administration functions.
* High level of organization skills.
* Ability to multitask.
* HS diploma and experience in administrative secretarial functions.
* Two years of experience in quality functions (preferred).
* Part time - 29 hours a week.
* Flexible work schedule - Monday through Friday.
* Less than 5%.