Medical Laboratory Quality Assurance Specialist
4 days ago
We are seeking a highly skilled and experienced Medical Laboratory Quality Assurance Specialist to join our team at Benton Roofing. This is a unique opportunity for a qualified professional to oversee the implementation and maintenance of quality systems, ensuring compliance with regulatory standards and driving continuous improvement initiatives.
Key Responsibilities- Audit Management:
- Lead and manage all vendor, internal, customer, and FDA regulatory audits.
- Prepare detailed audit reports and oversee the implementation of corrective actions.
- Ensure continuous compliance with all regulatory and accreditation requirements.
- ISO/IEC 17025 Accreditation:
- Lead and manage ISO/IEC 17025:2017 accreditation audits.
- Oversee the implementation of policies and procedures to maintain accreditation.
- Ensure laboratory practices align with international quality standards.
- Project & Personnel Management:
- Supervise and manage the quality team, providing guidance and leadership.
- Oversee multiple quality-focused projects to enhance laboratory operations.
- Foster a culture of continuous improvement and compliance.
- SOP and Documentation Management:
- Author, review, and revise Standard Operating Procedures (SOPs) to ensure consistency and accuracy.
- Oversee laboratory notebooks, equipment logbooks, calibration records, and raw data documentation.
- Ensure all documentation aligns with regulatory requirements and best practices.
- Training & Proficiency Programs:
- Oversee the development and execution of our training programs for quality assurance.
- Manage the Proficiency Testing Program to ensure compliance and staff competency.
- Develop and implement quality training initiatives for laboratory personnel.
- Collaboration & Quality Improvement:
- Work closely with laboratory management to address corrective actions and client complaints.
- Champion quality improvements within the laboratory through proactive initiatives.
- Collaborate with stakeholders to drive innovation in quality management systems.
- Regulatory Compliance & Reporting:
- Ensure adherence to GLP, GMP, and ISO regulations in all quality assurance functions.
- Prepare and present Laboratory Quality Reports to the Director of Quality and Director of Operations.
- Stay informed on regulatory changes and implement necessary updates.
- Client & Business Development Support:
- Assist Business Development with quality-related client inquiries.
- Ensure that client quality expectations and regulatory requirements are met.
- Support external client interactions regarding quality assurance matters.
- Meetings & Professional Development:
- Lead and participate in Quality Management meetings to drive continuous improvement.
- Engage in professional development opportunities as directed by the Director of Quality.
- Stay current with industry trends and regulatory updates.
- Perform additional duties as assigned by the Director of Quality.
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