The QA Manager will be responsible for facilitating communication between business operations and quality assurance, overseeing the quality of operations, managing pre-analytical and post-analytical phases, including reagent quality, method performance, and quality control metrics, ensuring accurate test results, monitoring turnaround times, addressing client and employee concerns, and driving continuous quality improvement efforts.

Key Responsibilities:

• Ensure adherence to and maintain awareness of various regulatory requirements, such as CAP, FDA, CLIA, HIPAA, OSHA, COLA, etc.
• Oversee the Quality Management System (QMS), which includes conducting quality audits, tracking quality metrics, and monitoring incident reports and corrective actions.
• Manage document control and organize records to ensure they are neat, accessible, and easily retrievable.
• Drive ongoing improvements in quality and processes.
• Provide support for both internal and external investigations regarding complaints and deviations.
• Design and implement training programs that teach the effective use of quality tools in the workplace.
• Annually assess and document the performance of all departmental staff, as delegated by the Laboratory Director.
• Ensure patient test results are not reported until corrective actions have been taken and the test system is operating correctly.
• Report on quality performance to the executive and laboratory management teams, highlighting areas for improvement.
• Perform additional tasks as assigned.

Safety and Compliance Responsibilities:

• Adhere to relevant legal standards and regulations, including those within the Compliance Process, Code of Conduct, State, COLA, and CLIA guidelines.
• Report concerns or suspected incidents of non-compliance to laboratory management.
• Cooperate with monitoring and audit processes and investigations.
• Ensure the laboratory maintains its licensing status.
• Contribute to maintaining a safe, clean, and secure work environment by supporting established procedures, rules, and regulations.

Required Qualifications and Experience:

• At least 4 years of experience in Quality Management within a laboratory environment.
• Ability to handle multiple tasks with professionalism and discretion.
• Excellent verbal and written communication skills.
• Strong critical thinking and problem-solving capabilities.
• Ability to manage highly confidential and proprietary information related to quality and process.
• Proficiency in computer software, including spreadsheets, word processing, and Microsoft Office.
• Knowledge of CLIA, COLA, and State regulations governing laboratory operations.
• Familiarity with OSHA laws and regulations.
• A Bachelor’s degree in a technical field, or equivalent academic and professional experience.