Position Details
About this role
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.
Key Responsibilities
- 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
Technical Overview
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.
Ideal Candidate
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.
Must-Have Skills
None listed
Required Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of regulatory experience in GMP/GxP, No vendor qualification or audit experience, Inability to travel as needed, Citizenship/work eligibility not satisfied
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