Quality Assurance Lead — Plasma Center Compliance

CSL Vifor; Springfield (MO); On-site; USD 60,000 - 85,000; Full time

Job summary

CSL Vifor is seeking a Quality Assurance professional in Springfield, MO to monitor plasma center processes and ensure compliance with CSL SOPs, CLIA/COLA, and governing regulations. The role partners with management to drive training, audits, and continuous improvement while safeguarding patient and donor data.

Key duties include final QA release, training management, and coordinating corrective actions, with responsibilities spanning internal and external audits and adherence to HSE/OSHA

Qualifications

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

Responsibilities

• Perform final QA review and release for all shipment and related documents to meet customer specifications.
• Ensure center records QA review for thoroughness, accuracy and timeliness; initiate investigations and corrective actions as needed.
• Maintain and review Plasma center training documents for CSL procedures and regulatory requirements.
• Maintain Learning Management System data integrity, reporting and data analysis.
• Schedule, coordinate and monitor delivery of all training (new hire, annual, retraining).
• Collaborate with center management to deliver retraining for quality improvements.
• Conduct periodic process assessments to ensure compliance and corrective actions with management.
• Identify non-conformities to CSL SOPs and participate in quality team activities and audits.
• Promote Safety, Health and Environment policies and ensure training practices are followed.
• Lead internal audits and respond to deficiencies; host external audits when needed.
• Initiate, investigate and close Trackwise reports; ensure corrective actions are effective.

Skills

Leadership

Customer Service

Regulated Environment

Attention to Detail

Quality Systems

Education

High school diploma

Associate/Bachelor's in business administration or biological sciences

Job description

CSL Vifor is seeking a Quality Assurance professional in Springfield, MO to monitor plasma center processes and ensure compliance with CSL SOPs, CLIA/COLA, and governing regulations. The role partners with management to drive training, audits, and continuous improvement while safeguarding patient and donor data.

Key duties include final QA release, training management, and coordinating corrective actions, with responsibilities spanning internal and external audits and adherence to HSE/OSHA