Quality Associate - Digital Archive

Job Overview

We seek a meticulous Quality Associate to join a contract role at a pharmaceutical manufacturing site in the Kansas City Metropolitan Area. This position is integral to a pivotal digital transformation effort, centered on converting physical quality records into a modern digital archive system while ensuring compliance with Good Practice (GxP) standards. The role involves close collaboration with Global IT teams and ongoing process development to support site operations beyond project completion.

Key Responsibilities

• Assist the implementation of a Global Digital Archive System in partnership with Global IT.
• Label, categorize, and maintain an inventory of documentation for digital archiving purposes.
• Ensure accuracy of metadata for both physical and electronic records.
• Prepare and revise Standard Operating Procedures and best practice guidelines.
• Provide training to Quality Assurance staff on new archival systems and workflows.
• Maintain audit readiness by managing accurate and easily retrievable records.

Qualifications and Requirements

• A Bachelor’s degree in a scientific discipline is preferred, or a high school diploma with a minimum of four years’ experience in pharmaceutical or biotechnology environments.
• Proficiency in Microsoft Office Suite including Word, Excel, PowerPoint, and Outlook.
• High attention to detail suitable for repetitive tasks requiring consistent accuracy involving data handling and physical document management.

Desirable Attributes

• One to three years of experience in Quality Assurance, Records Management, or regulated administrative roles.
• Experience working with digital archive systems within pharmaceutical or biotech settings.
• Ability to adapt quickly to new software and collaborate with cross-functional IT teams.
• Capable of working independently while upholding strict data integrity and quality standards.

Work Conditions

• This is an on-site role based on day shifts with minimal travel required.
• No night or weekend shifts are expected under normal scheduling.