The Lab QA Supervisor oversees quality assurance operations within a toxicology laboratory, ensuring compliance with regulatory standards, accuracy of test results, and continuous improvement of laboratory processes. This role supports both scientific integrity and regulatory readiness.
1. Quality Assurance Oversight
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Develop, implement, and maintain QA programs for toxicology testing.
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Ensure compliance with standards such as GLP (Good Laboratory Practice), CLIA, CAP, and FDA regulations.
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Monitor laboratory processes to ensure data integrity and reliability.
2. Audits & Compliance
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Conduct internal audits and inspections.
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Prepare for external audits by regulatory agencies and accrediting bodies.
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Investigate deviations, non-conformances, and implement corrective/preventive actions (CAPA).
3. Documentation & Reporting
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Review and approve SOPs (Standard Operating Procedures), protocols, and reports.
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Maintain QA records, audit trails, and validation documentation.
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Ensure proper documentation of toxicology test results and procedures.
4. Method Validation & Data Review
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Oversee validation and verification of toxicology testing methods (e.g., drug screening, LC-MS/MS).
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Review analytical data for accuracy, precision, and compliance.
5. Staff Supervision & Training
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Supervise QA staff and support laboratory personnel on QA practices.
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Conduct training on quality systems, regulatory requirements, and documentation standards.
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Evaluate staff performance related to QA compliance.
6. Continuous Improvement
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Identify areas for process improvement and implement quality initiatives.
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Track quality metrics (e.g., error rates, turnaround times).
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Promote a culture of quality and regulatory compliance.
Education
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Bachelor’s or Master’s degree in Chemistry, Biology, Toxicology, or related field.
Experience
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3–7+ years in a toxicology or clinical laboratory.
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Experience in QA/QC and regulatory compliance.
Skills
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Strong knowledge of GLP, CLIA, CAP, and FDA guidelines.
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Experience with toxicology instrumentation (e.g., GC-MS, LC-MS/MS).
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Excellent analytical, organizational, and leadership skills.
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Attention to detail and problem-solving ability.
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Laboratory setting with exposure to biological samples and chemicals.
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May require occasional extended hours during audits or investigations.
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Leadership and team management
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Regulatory expertise
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Critical thinking
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Communication and documentation
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Ethical judgment and integrity
