Plasma Center Quality Lead & Compliance

CSL; Indianapolis (IN); On-site; USD 55,000 - 90,000; Full time

Job summary

CSL is seeking a quality-focused professional to support the Assistant Manager of Quality in monitoring plasma center processes, ensuring compliance with CSL SOPs and all applicable regulations. You will help train staff, maintain records, and coordinate quality activities to support operations.

Your role includes performing final QA release for shipments, conducting audits, maintaining training documentation, managing Trackwise reports, and partnering with center management to drive continuous

Qualifications

• Minimum 1-year leadership experience or equivalent in a regulated environment.
• Strong customer service and communication skills.
• Understanding of Quality Systems and regulated training requirements.

Responsibilities

• Perform final QA review and release for all shipment documents to ensure customer specifications.
• Maintain center QA records for thoroughness, accuracy and timeliness; document deficiencies and corrective actions.
• Coordinate and monitor staff training; maintain Learning Management System data integrity.
• Lead internal audits and assist with external audits, ensure compliance with cGMP, OSHA, FDA and CSL procedures.
• Develop and implement corrective actions; track effectiveness and close Trackwise reports promptly.
• Support continuous improvement initiatives with center management to enhance quality, safety and training.

Skills

Leadership

Customer service

Critical thinking

Organizational skills

Quality systems

Education

High school diploma

Associate degree

Bachelor's degree

Job description

CSL is seeking a quality-focused professional to support the Assistant Manager of Quality in monitoring plasma center processes, ensuring compliance with CSL SOPs and all applicable regulations. You will help train staff, maintain records, and coordinate quality activities to support operations.

Your role includes performing final QA release for shipments, conducting audits, maintaining training documentation, managing Trackwise reports, and partnering with center management to drive continuous