Quality - Quality Assurance Associate

Position Title: Quality Assurance Associate (Preferred Job Title: Plasma Quality Auditor)
Work Location: Remote (US) with travel to supplier locations as needed
Assignment Duration: 6 Months
Work Schedule: Standard business hours. Frequent travel required. Overnight travel expected greater than 50% of the time.

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.

Major Accountabilities:

• 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

Minimum Required Qualifications:

• 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

Preferred / Nice to Have Qualifications:

• 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
• Experience auditing supplier quality systems
• Background in Quality Assurance, Quality Systems, Supplier Quality, Compliance, or Plasma Operations

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $40.00/hr - $50.00/hr.