Quality Assurance Lead – GMP & CAPA

CSL Plasma; Waukegan (IL); On-site; USD 85,000 - 120,000; Full time

Job summary

Searchbox l.l.c. in Illinois seeks a Quality Assurance leader to ensure the center remains inspection-ready by adhering to SOPs, quality systems, and regulatory requirements. You will drive CAPA processes, audit readiness, and continuous improvement across the site.

As the QA lead, you will manage staff, coordinate audits with regulatory bodies and customers, report to management, and collaborate with operations to sustain product quality and compliance in a dynamic, regulated environment.

Qualifications

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

Responsibilities

• Ensure center is inspection ready at all times by managing SOP adherence, compliance policies and the quality system.
• Prepare regular reports to center, area and corporate quality management on quality and system status.
• Manage site Quality Control program including calibrations, sampling, competency checks, KPIs and KPI analysis.
• Lead and develop direct reports, recruit, hire, conduct performance reviews and enforce corrective actions up to termination.
• Develop programs to streamline center processes for better customer/donor service, product yields and financial results while ensuring quality.
• Provide feedback to staff on GMP observations; report concerns to area management and recommend remedial actions.
• Lead audits as the key quality representative for supplier, customer and regulatory audits; coordinate CAPA and closure.
• Maintain a clean work environment and ensure supplies; comply with HSE and OSHA policies; promote safety.
• Adhere to HR policies and ensure HR compliance within center management.
• Comply with federal, state and local regulatory and company policies and procedures.
• Notify relevant leadership of events affecting safety, quality, identity, purity or potency; escalate as needed.
• Maintain confidentiality of personnel, donor and centre information; understand policies on hyper immune programmes.
• Lead investigations into deviations to determine root cause, corrective actions and effectiveness checks.

Skills

Leadership

Regulatory knowledge

Quality management

CAPA handling

Education

Bachelor degree in scientific discipline/life sciences

Tools

Quality systems

Job description

Searchbox l.l.c. in Illinois seeks a Quality Assurance leader to ensure the center remains inspection-ready by adhering to SOPs, quality systems, and regulatory requirements. You will drive CAPA processes, audit readiness, and continuous improvement across the site.

As the QA lead, you will manage staff, coordinate audits with regulatory bodies and customers, report to management, and collaborate with operations to sustain product quality and compliance in a dynamic, regulated environment.