Contract Length: 12 months (potential for extension)

Location: Elwood, KS On-site, 5 days/week 

About the Role

Our client, a global life sciences manufacturer, is modernizing its quality records archive — transitioning from a fully manual, paper-based system to a digital archive platform. This is a net-new role created specifically to support that transition. The QA Associate will play a central role in physically preparing, labeling, and inventorying archival materials, and in supporting the rollout of a new electronic archive system in close partnership with Global IT and the Quality organization.

This role is largely independent and execution-focused: roughly 90% of the work is heads-down document handling, labeling, and data entry, with the remaining time spent coordinating with IT on system logistics and with the Quality team on documentation standards.

What You’ll Do

• Physically prepare, label, and organize documentation in accordance with archiving requirements
• Maintain a thorough and accurate electronic inventory of all archived files
• Transcribe document titles and metadata accurately, ensuring consistency between physical top-tab indexing and the electronic archive system
• Support the local rollout of the new digital archive system, including user-workflow testing alongside Global IT to confirm site-specific Quality requirements are met
• Ensure all archiving activities align with the organization’s Quality standards and applicable global regulatory requirements (e.g., GxP)
• Support QA during audits or inspections by enabling rapid retrieval of archived records, physical or digital
• Assist in creating and updating standard work instructions/SOPs for site-wide archival procedures (working from existing templates rather than authoring from scratch)
• Help train the QA department on the new digital archive system and updated archival processes
• Collaborate with site QA to help stand up an offsite storage process, including shipment and inventory management once that phase begins
• Take on document quantification and categorization tasks (by document type and regulatory urgency) as needed while system implementation is underway
• Other duties as assigned

What You’ll Need

• Bachelor’s degree (scientific discipline preferred) OR a High School diploma plus 4+ years of relevant industry experience (pharmaceutical/biotech)
• Strong working knowledge of GxP and regulatory documentation practices — this matters more than familiarity with any specific archive software
• Exceptional attention to detail, with demonstrated accuracy in repetitive data entry and physical organization tasks
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Ability to work independently, execute against clear deliverables, and manage your own pace without close daily oversight
• Strong, structured communication skills — able to clearly flag issues or bottlenecks along with a proposed path forward
• Demonstrated learning agility — comfortable picking up new software platforms and willing to grow into the subject-matter-expert role for the new system

Nice to Have

• 1–3 years of experience in Quality Assurance, Records Management, or a similar regulated administrative role
• Experience with any digital archive or document/records management system within pharma/biotech (direct experience with the specific platform being implemented is not required)
• General technical writing ability — comfortable translating source material (e.g., an equipment manual) into a clear, appropriately scoped procedure using existing templates
• Exposure to offsite storage vendor management (shipping, chain of custody, inventory reconciliation)