Plasma Quality Auditor
Quality Assurance
Remote
Posted on Jul 31, 2026
Our client is currently seeking a Plasma Quality Auditor
Job Title: Plasma Quality Auditor
Contract Duration: 6 Months
Location: Remote (United States) with travel to supplier locations as needed
Travel Requirement: Frequent travel required. Overnight travel expected greater than 50% of the time.
Job Summary
The Plasma Quality Auditor is responsible for conducting qualification and recertification audits of U.S.-based plasma suppliers and contracted organizations that provide goods and services used in plasma manufacturing operations. This role evaluates supplier compliance with internal procedures, regulatory requirements, industry standards, and customer expectations.
The auditor will perform on-site supplier audits, assess Quality Management Systems (QMS), review donor suitability processes, plasma collection and storage practices, and evaluate operational and quality-related activities to ensure compliance and quality excellence.
Key Responsibilities
Conduct supplier qualification and recertification audits.
Assess compliance with applicable regulatory requirements, industry standards, and quality expectations.
Review supplier Quality Management Systems (QMS) and operational processes.
Prepare audit reports and document audit findings.
Lead audit discussions and closeout meetings with supplier leadership teams.
Evaluate corrective and preventive actions (CAPAs) for effectiveness.
Support root cause investigations and continuous improvement initiatives.
Manage supplier quality activities and supplier-related investigations.
Participate in risk assessments and quality improvement projects.
Maintain accurate audit documentation and records.
Required Qualifications
Bachelor's degree in a scientific discipline or an equivalent combination of education and experience.
Minimum 2 years of quality auditing experience.
Experience conducting compliance, quality system, supplier, operational, or regulatory audits.
Strong written and verbal communication skills, including audit report writing.
Ability to interpret and apply complex regulations, standards, and quality requirements.
Ability and willingness to travel overnight more than 50% of the time.
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