Lab Quality Assurance Auditor

Job Description

Job Description

Overview

The Lab Quality Assurance Auditor plays a crucial role in ensuring the accuracy, precision, and compliance of laboratory operations with industry standards and regulations.

They are responsible for conducting comprehensive audits, implementing quality control measures, and providing recommendations for process improvement to maintain the highest standards of quality and accuracy in laboratory procedures.

Key responsibilities

• Conduct thorough audits of laboratory procedures, documentation, and records to ensure compliance with regulatory standards and quality assurance protocols
• Develop and implement quality control processes and procedures to maintain the accuracy and precision of laboratory testing
• Evaluate and monitor the effectiveness of quality assurance programs and initiatives, identifying areas for improvement and recommending corrective actions
• Collaborate with laboratory staff to provide guidance on compliance with quality and regulatory requirements, offering training and support as needed
• Analyze data and results to identify trends, anomalies, and potential non-conformities, providing recommendations for corrective and preventive actions
• Review and update quality assurance documentation, standard operating procedures, and policies to reflect current industry standards and best practices
• Participate in external audits and regulatory inspections, ensuring readiness and facilitating the resolution of audit findings
• Conduct risk assessments and contribute to the development of risk management strategies to mitigate potential quality and compliance risks
• Communicate quality assurance findings, trends, and recommendations to key stakeholders, fostering a culture of continuous improvement and accountability
• Stay abreast of industry trends, regulatory updates, and advancements in quality assurance practices to support ongoing compliance and performance improvement

Required qualifications

• Bachelor’s degree in a relevant scientific field such as biology, chemistry, or a related discipline
• Proven experience in quality assurance, auditing, or compliance within a laboratory setting
• Demonstrated knowledge of regulatory requirements, quality control principles, and industry best practices
• Strong analytical skills with the ability to interpret complex data and identify patterns or discrepancies
• Excellent understanding of laboratory procedures, methodologies, and instrumentation, with a focus on ensuring accuracy and precision
• Effective communication skills with the ability to collaborate with cross-functional teams and communicate findings to diverse stakeholders
• Detail-oriented approach with a commitment to upholding the highest standards of quality and compliance
• Ability to work independently, prioritize tasks, and manage multiple projects simultaneously
• Certification in quality assurance or auditing (e.g., Certified Quality Auditor, ISO 9001 Lead Auditor) is highly desirable
• Familiarity with industry standards such as Good Laboratory Practices (GLP) and ISO / IEC 17025 is advantageous
• Experience with quality management systems and proficiency in using quality assurance software and tools
• Adherence to ethical and professional standards, with a focus on promoting integrity and accountability in all aspects of quality assurance
• Strong problem-solving abilities and a proactive mindset to drive continuous improvement initiatives
• Ability to adapt to evolving regulatory requirements and contribute to the development of compliant, efficient processes
• Commitment to ongoing professional development and continuous learning to stay current with quality assurance trends and best practices
23 hours ago