Quality Compliance & Training Specialist

CSL; State College (Centre County); On-site; USD 45,000 - 65,000; Full time

Job summary

CSL Plasma Center seeks a Quality Assurance professional to monitor processes, ensure compliance with CSL SOPs and regulatory requirements, and support center audits and training management. This role reports to the Assistant Manager of Quality and collaborates with center management on continuous improvement plans.

Responsibilities include QA release of shipments, investigation of deficiencies, training schedule management, and leading internal/external audits to uphold cGMP, CLIA/COLA, and FDA

Qualifications

• Minimum 1-year leadership experience in a regulated environment.
• Strong customer service skills.
• Strong critical reasoning, decision-making and problem solving.
• Organizational skills to handle multiple tasks and deadlines.
• Understanding of quality systems and regulated training requirements.

Responsibilities

• Perform final QA review and release for shipments and documents to meet customer specs.
• Review center records for thoroughness, accuracy and timeliness; investigate deficiencies.
• Maintain and review training documents to ensure CSL procedures and regulatory compliance.
• Manage Learning Management System data integrity and reporting.
• Coordinate delivery of all training (new hire, annual, retraining) to meet requirements.
• Identify and communicate non-conformities; participate in quality meetings when AMQ unavailable.
• Lead audits, host external audits, and develop center responses for deficiencies.

Skills

Leadership

Customer service

Critical thinking

Organizational skills

Quality systems

Education

High school diploma or equivalent

Associate or Bachelor’s degree preferred

Job description

CSL Plasma Center seeks a Quality Assurance professional to monitor processes, ensure compliance with CSL SOPs and regulatory requirements, and support center audits and training management. This role reports to the Assistant Manager of Quality and collaborates with center management on continuous improvement plans.

Responsibilities include QA release of shipments, investigation of deficiencies, training schedule management, and leading internal/external audits to uphold cGMP, CLIA/COLA, and FDA