QA Associate - Temp 12 month assignment

Temporary QA role focused on vendor onboarding, qualification audits, and CAPA tracking to ensure GxP compliance within Marken PL services. This 12-month assignment emphasizes cross-functional collaboration and data-quality processes.

• Maintain compliance with quality management system and regulatory requirements
• Manage vendor qualification program and audits
• Prepare audit reports and track CAPAs
• Conduct vendor risk assessments and document data integrity
• Travel as needed for duties

QA & Testing within a regulated environment; emphasis on vendor qualification, audits, CAPA, and regulatory standards (GxP, GDP, GMP). Familiarity with Quality Management Systems and audit reporting tools is expected.

The ideal candidate is an entry- to mid-level quality assurance professional with hands-on exposure to GMP/GxP environments, vendor qualification processes, and regulatory audits; capable of coordinating CAPAs and audit responses with cross-functional teams.