Quality & Compliance Specialist

CSL; Austin (TX); On-site; USD 55,000 - 85,000; Full time

Job summary

CSL is seeking a QA Coordinator in Austin to monitor plasma center processes and ensure compliance with CSL procedures and regulatory requirements. The role emphasizes training, SOP adherence, and timely QA reviews of shipments and records to support operations and quality objectives.

Responsibilities include final QA release, training documentation, LMS data management, and coordinating audits. Strong knowledge of cGMP, FDA regulations, and safety practices is preferred to ensure center

Qualifications

• Knowledge of QA/QC processes in a regulated environment.
• Experience with training programs and regulatory documentation.
• Familiarity with cGMP, FDA and OSHA requirements.

Responsibilities

• Perform final QA review and release for shipments and documents.
• Maintain QA records for thoroughness, accuracy and timeliness.
• Initiate investigations and document deficiencies; determine corrective actions.
• Maintain training documents to comply with CSL procedures and regulations.
• Manage Learning Management System data, reports and analysis.
• Schedule, coordinate and monitor employee training (new hire, retraining).
• Collaborate to deliver retraining for quality improvements.
• Conduct periodic process assessments and corrective action planning.
• Identify non-conformities and lead quality team discussions.
• Promote safety policies and ensure compliant practices.
• Lead or participate in internal audits and respond to deficiencies.

Skills

Leadership

Quality systems

Training coordination

Regulatory knowledge

Auditing

Education

High school diploma

Associate or bachelor’s in business or biological sciences preferred

Tools

LMS

Job description

CSL is seeking a QA Coordinator in Austin to monitor plasma center processes and ensure compliance with CSL procedures and regulatory requirements. The role emphasizes training, SOP adherence, and timely QA reviews of shipments and records to support operations and quality objectives.

Responsibilities include final QA release, training documentation, LMS data management, and coordinating audits. Strong knowledge of cGMP, FDA regulations, and safety practices is preferred to ensure center