QA Associate-Document Control

The Quality Assurance Associate is responsible for handling tasks associated with Document Control, including processing, archival, filing, scanning, indexing and formatting new and existing documents within the framework of Veeva Vault Quality Docs software. This position involves familiarity and experience with cGMP Quality System processes and supports all functional areas with needs related to QMS documentation.

Duties and Responsibilities

• Maintains all controlled and other Quality System documents.
• Performs duties relating to maintaining electronic and hard copy document files and maintaining records for off-site storage.
• Performs all aspects of the document change control system which includes updating the electronic system and archiving original copies.
• Reviews change control submissions for thoroughness and adherence to documented procedures.
• Supports and assists all functional departments with regards to documentation control functions.
• Leads efforts to improve migration of documentation from a paper system to an electronic system, including the creation of folder structures and naming conventions.
• Performs other duties as required.

Desired Knowledge and Abilities:

• Well-organized and detail-oriented with strong technical skills, solid written and verbal communication skills, and proven ability to multitask.
• Strong interpersonal skills and the ability to effectively collaborate with others in a dynamic team environment.
• Capable of supporting multiple projects simultaneously in a deadline-driven environment.
• Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves in order to thrive in small company environment.
• High level of proficiency in Microsoft Word, Excel, and Project.

Education and Experience:

• Bachelor's degree in Life/Health Sciences.
• 1-3 years of experience including experience within a regulated environment (e.g. ISO 9001/13485 or GXP)
• Experience in electronic documentation management systems, preferably Veeva Vault Quality Docs