Quality Assurance Lead, Plasma Center Operations

CSL; Wilkes-Barre (Luzerne County); On-site; USD 55,000 - 75,000; Full time

Job summary

CSL Plasma is seeking a Quality Assurance role to monitor plasma center processes and ensure compliance with CSL procedures and regulatory requirements. The position supports operations, collaborates with management, and represents the center during audits.

You will manage training activities, review records, and participate in ongoing quality system improvements to maintain high standards for safety and effectiveness in plasma collection and processing.

Qualifications

• Minimum 1-year leadership experience or equivalent in a regulated environment.
• Strong customer service skills.
• Strong critical reasoning, decision-making and problem solving skills to analyze situations.
• Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities.
• Understand Quality Systems and/or regulated training requirements.

Responsibilities

• Perform final QA review and release for all shipment and associated documents to ensure shipment meets customer specifications.
• Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action.
• Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOPs, CLIA/COLA and other applicable requirements.
• Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.
• Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and retraining to meet center or other training and regulatory requirements.

Skills

Leadership experience

Customer service

Critical thinking

Decision making

Problem solving

Attention to detail

Organizational skills

Education

High school diploma or equivalent

Associate or Bachelor’s degree preferred

Tools

Learning Management System

Job description

CSL Plasma is seeking a Quality Assurance role to monitor plasma center processes and ensure compliance with CSL procedures and regulatory requirements. The position supports operations, collaborates with management, and represents the center during audits.

You will manage training activities, review records, and participate in ongoing quality system improvements to maintain high standards for safety and effectiveness in plasma collection and processing.