Bilingual Quality Assurance Lead

CSL; San Juan (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

CSL Plasma in San Juan, Puerto Rico, seeks an Assistant Manager of Quality (Bilingual – English/Spanish) to oversee the center's quality system, SOP adherence, and regulatory compliance in a fast-paced plasma center.

You will lead QA staff, manage KPIs, CAPA, audits, and continuous improvement while ensuring GMP adherence, patient/donor safety, and alignment with corporate quality management.

Qualifications

• Bachelor degree in scientific discipline/life sciences or related discipline.
• 5+ years' experience related to quality and regulatory/ plasma industry.
• Demonstrated leadership/supervisory experience.
• Knowledge of government and industry regulations.

Responsibilities

• Ensure center is ‘inspection ready’ by maintaining SOPs, quality system, and adherence to quality principals.
• Manage site Quality Control program including calibrations, sampling, KPIs, trends, and CAPA.
• Lead QA staff; conduct performance reviews and corrective actions up to termination.
• Coordinate audits with suppliers, customers, and regulators; drive remediation and timely closure.
• Promote safety and ensure compliance with HR, OSHA/HSE policies.

Skills

Leadership

Quality assurance

Regulatory knowledge

GMP knowledge

Bilingual English/Spanish

Education

Bachelor's degree in life sciences

Job description

CSL Plasma in San Juan, Puerto Rico, seeks an Assistant Manager of Quality (Bilingual – English/Spanish) to oversee the center's quality system, SOP adherence, and regulatory compliance in a fast-paced plasma center.

You will lead QA staff, manage KPIs, CAPA, audits, and continuous improvement while ensuring GMP adherence, patient/donor safety, and alignment with corporate quality management.