Quality & Compliance Lead, Plasma Center

CSL; Toledo (OH); On-site; USD 55,000 - 75,000; Full time

Job summary

CSL Plasma Toledo is seeking a QA-focused professional to assist the Assistant Manager of Quality in monitoring center processes for compliance with CSL SOPs and regulatory requirements. Responsibilities include QA review of shipments, training coordination, and supporting internal/external audits.

You will maintain training records, manage the Learning Management System, and drive corrective actions in collaboration with center management to uphold cGMP and safety standards.

Qualifications

• Minimum 1 year of leadership experience or equivalent in a regulated environment.
• Strong customer service skills.
• Strong critical reasoning, decision-making and problem solving to analyze situations.
• Excellent organizational skills and attention to detail to manage multiple tasks and deadlines.
• Understanding of Quality Systems and regulated training requirements.

Responsibilities

• Perform final QA review and release for shipment-related documents to ensure customer specifications are met.
• Review center QA records for thoroughness and timeliness; document deficiencies and determine corrective actions.
• Coordinate and monitor training activities, policies, and processes at the center level.
• Maintain Learning Management System data integrity, reporting, and analysis to comply with standards.
• Lead and/or participate in internal audits and support external regulatory audits as needed.
• Initiate, investigate, and close Trackwise reports; verify corrective actions and effectiveness.
• Support center safety, compliance with SOPs and regulatory requirements (FDA, cGMP, OSHA, HIPAA, etc.).
• Assist in ongoing quality improvements and training across the center.

Skills

Leadership

Customer service

Analytical thinking

Organizational skills

Quality systems understanding

Education

Associate or Bachelor’s in business or biological sciences

Job description

CSL Plasma Toledo is seeking a QA-focused professional to assist the Assistant Manager of Quality in monitoring center processes for compliance with CSL SOPs and regulatory requirements. Responsibilities include QA review of shipments, training coordination, and supporting internal/external audits.

You will maintain training records, manage the Learning Management System, and drive corrective actions in collaboration with center management to uphold cGMP and safety standards.