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