Quality Compliance & Training Specialist

CSL Vifor; Indianapolis (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

CSL Vifor in Indianapolis seeks a Quality Assurance Specialist to support the Assistant Manager of Quality by monitoring plasma center processes and regulatory compliance with CSL procedures, SOPs and applicable laws.

You will coordinate training, maintain records, perform QA reviews, assist in audits, investigate deficiencies and implement corrective actions in line with cGMP, HIPAA and OSHA standards.

Qualifications

• Leadership experience or equivalent in a regulated environment.
• Strong customer service skills and ability to communicate clearly.
• Ability to analyze situations and make sound decisions.
• Excellent organizational skills with attention to detail.
• Understanding of Quality Systems and regulatory training requirements.

Responsibilities

• Perform final QA review and release for shipments and documents to meet customer specs.
• Maintain QA review of center records; initiate investigations and corrective actions.
• Maintain training documents to comply with CSL procedures and regulatory requirements.
• Manage Learning Management System data integrity and reporting.
• Coordinate and monitor center training (new hire, annual, retraining).
• Collaborate on Quality Management System to address issues and retraining.
• Conduct periodic process assessments and document deficiencies and corrective actions.
• Identify non-conformities to SOPs and participate in quality team activities.
• Promote Safety, Health and Environment policies and safety practices.
• Lead internal audits and assist with external audits by regulators and customers.
• Initiate and close Trackwise reports and verify corrective actions.
• Maintain a clean, safe work environment and comply with HSE and OSHA policies.

Skills

Leadership experience

Customer service

Critical reasoning

Decision making

Problem solving

Organizational skills

Quality systems understanding

Education

High school diploma or equivalent; Associate or Bachelor’s degree preferred

Job description

CSL Vifor in Indianapolis seeks a Quality Assurance Specialist to support the Assistant Manager of Quality by monitoring plasma center processes and regulatory compliance with CSL procedures, SOPs and applicable laws.

You will coordinate training, maintain records, perform QA reviews, assist in audits, investigate deficiencies and implement corrective actions in line with cGMP, HIPAA and OSHA standards.