Quality Auditor

The Plasma Quality Auditor is responsible for performing qualification and recertification audits of US plasma suppliers and contracted organizations that provide goods and services used in the manufacturing of US plasma.

This position evaluates supplier compliance with company procedures, applicable regulatory requirements, industry standards, and customer requirements. The auditor will conduct on-site supplier audits, assess Quality Management Systems (QMS), review donor suitability processes, plasma collection and storage practices, and other operational and quality-related activities.

• Conducting supplier qualification and recertification audits
• Assessing compliance with FDA, CLIA, OSHA, PPTA, AABB, EMA, and other applicable regulations and standards
• Reviewing supplier quality systems and operational processes
• Writing audit reports and documenting findings
• Leading audit discussions and closeout meetings with supplier leadership
• Evaluating corrective actions and CAPAs
• Supporting root cause investigations and process improvement initiatives
• Managing supplier controls activities and supplier-related investigations
• Participating in risk assessments and quality improvement projects

• Bachelor's Degree in a scientific discipline or equivalent combination of education and experience
• Minimum two (2) years of quality auditing experience
• Experience conducting compliance, quality system, supplier, operational, or regulatory audits
• Strong report writing and communication skills
• Ability to interpret and apply complex regulations and standards
• Willingness and ability to travel overnight more than 50% of the time

• Plasma industry experience strongly preferred
• Minimum one (1) to two (2) years of blood banking, plasma collection, or plasmapheresis industry experience
• ASQ Certified Quality Auditor (CQA) certification preferred
• Other recognized Quality Auditor certifications will be considered
• Knowledge of FDA, CLIA, OSHA, PPTA, AABB, EMA, and cGMP requirements
• Background in Quality Assurance, Quality Systems, Supplier Quality, Compliance, or Plasma Operations

Russell Tobin offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.