Quality & Compliance Lead - Plasma Center

CSL

Round Rock (TX)

On-site

USD 65,000 - 90,000

Full time

3 days ago
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Job summary

CSL is seeking an Associate Quality Analyst to support the Assistant Manager of Quality by monitoring plasma center processes, ensuring compliance with CSL SOPs and regulatory requirements to support operations and quality.

You will perform final QA review and release shipments, manage training records, coordinate audits, and drive corrective actions while maintaining data integrity in the LMS and ensuring safety and training compliance.

Qualifications

  • Minimum 1-year leadership experience or equivalent in a regulated environment.
  • Strong customer service skills.
  • Strong critical reasoning, decision-making and problem solving skills.
  • Organizational skills with ability to multitask in a fast-paced environment.
  • Understand Quality Systems and/or regulated training requirements.

Responsibilities

  • Perform final QA review and release for shipments and documents.
  • Maintain center records QA review for thoroughness and accuracy.
  • Manage training documents to ensure CSL SOPs compliance.
  • Maintain Learning Management System data integrity and reporting.
  • Coordinate and monitor delivery of all training, including new hire and retraining.
  • Identify and communicate non-conformities to CSL’s SOPs and lead quality meetings.
  • Lead internal audits to ensure facility compliance with FDA, OSHA and CSL policies.
  • Close Trackwise reports with effective corrective actions.
  • Ensure safety and environmental policies are followed.
  • Assist with external audits and center responses.

Skills

Leadership
Regulatory knowledge
Quality assurance
Training management
Audit coordination

Education

High school diploma or equivalent
Associate or Bachelor's degree in business administration or biological sciences

Tools

TrackWise
LMS
Microsoft Excel

Job description

CSL is seeking an Associate Quality Analyst to support the Assistant Manager of Quality by monitoring plasma center processes, ensuring compliance with CSL SOPs and regulatory requirements to support operations and quality.

You will perform final QA review and release shipments, manage training records, coordinate audits, and drive corrective actions while maintaining data integrity in the LMS and ensuring safety and training compliance.

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