Quality Systems Lead - Plasma Center Compliance

Jobtailor

El Paso (TX)

On-site

USD 75,000 - 110,000

Full time

7 days ago
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Job summary

Jobtailor is seeking a Quality Assurance/Regulatory professional to oversee the plasma donor center's quality management system and drive continuous improvement. You will coordinate corrective actions, ensure donor safety, and maintain compliance with FDA and cGMP standards in a dynamic environment.

Responsibilities include leading audits, training staff, and implementing SOPs for quality control, with travel as needed.

Qualifications

  • Bachelor of Science degree or equivalent.
  • Certified in quality and compliance.
  • 2–5 years of related experience in medical and/or cGMP environment.
  • Experience with plasma or whole blood.
  • Ability to understand and assess FDA regulations.

Responsibilities

  • Evaluate processes and coordinate corrective actions at the plasma donor center.
  • Maintain quality management system and drive continuous improvement.
  • Lead audits and respond with corrective/preventive actions.
  • Ensure donor safety and product quality through SOPs.
  • Oversee training, staffing, and performance actions.

Skills

Quality management systems
Regulatory compliance
Root cause analysis
cGMP environment
Interpersonal communication
Time management
Problem solving
Donor suitability assessment
Training and development
Process improvement

Education

Bachelor of Science Degree

Tools

Quality Analysis Software
Compliance Management Tools
Data Management Systems

Job description

Jobtailor is seeking a Quality Assurance/Regulatory professional to oversee the plasma donor center's quality management system and drive continuous improvement. You will coordinate corrective actions, ensure donor safety, and maintain compliance with FDA and cGMP standards in a dynamic environment.

Responsibilities include leading audits, training staff, and implementing SOPs for quality control, with travel as needed.

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