Quality Assurance Specialist

Job Summary

To support the Quality Document Control and Training program, the contract-to-hire Quality Assurance Specialist will manage document workflows, ensure compliance with quality standards, and oversee training assignments in a remote setting.

Key responsibilities

• Independently manage the processing, review, approval, and archival of revision-controlled documents in the Electronic Document Management System (eDMS)
• Provide user support and guidance on document workflows and ensure documents meet compliance standards before approval
• Generate training compliance reports and support onboarding training activities within the eDMS

Required qualifications

• Bachelor's degree in a Life Sciences discipline preferred, not required
• Two years of experience in QA training and documentation within a pharmaceutical or biopharmaceutical GMP environment
• Proficiency in an eDMS/eLMS system, specifically MasterControl
• Familiarity with document change management and FDA quality systems
• Strong organizational and compliance skills with a high level of attention to detail