Lab Quality Assurance & Compliance Specialist

CSL; Knoxville (TN); On-site; USD 75,000 - 95,000; Full time

Job summary

CSL Plasma Services is seeking a Quality Assurance professional to oversee laboratory operations and ensure compliance with CLIA, FDA and other regulatory requirements. You will review quality records, track non-conformances, and drive corrective actions while supporting ongoing process improvements.

The role involves batch review and release for specialized programs, data validation, and ensuring competency across the CSLPS procedures and SOPs.

Qualifications

• Bachelor's Degree in a scientific field is required.
• Five or more years’ experience in a laboratory setting, including one-year experience in a regulated environment and one-year internal quality auditing experience.

Responsibilities

• QA oversight of laboratory operations to ensure regulatory compliance (CLIA, FDA, international) and customer specifications.
• Examines quality records for thoroughness, accuracy and timeliness; reports non-conformances.
• Maintains system to document, track and trend non-conformances and exceptions; reviews corrective actions.
• Supports Anti-D Lab and IRBC Manufacturing program; performs batch review and release.
• Conducts periodic process assessments; recommends changes to procedures to ensure compliance.
• Reviews data for validations; ensures adherence to cGMPs and SOPs; maintains validations index on site.
• Provides QA review and release for incoming reagents.
• Reviews personnel competency assessments for CSL procedures and regulatory requirements.
• Monitors complaints; investigates, determines root cause, and reports trends to management.
• Other duties as assigned.

Skills

Quality Assurance

Regulatory compliance

Process improvement

Data analysis

Education

Bachelor's Degree in a scientific field

Tools

Access

Excel

Job description

CSL Plasma Services is seeking a Quality Assurance professional to oversee laboratory operations and ensure compliance with CLIA, FDA and other regulatory requirements. You will review quality records, track non-conformances, and drive corrective actions while supporting ongoing process improvements.

The role involves batch review and release for specialized programs, data validation, and ensuring competency across the CSLPS procedures and SOPs.