POSITION SUMMARY :
The Senior Clinical Laboratory Quality Assurance Analyst is responsible for performing activities related to Clinical Laboratory Quality Assurance (QA) and Regulatory and serves as a QA and Regulatory resource for the laboratory testing personnel, the laboratory leadership team and internal support groups.
The broad scope and high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, familiarity with and the ability to analyze complex issues across all sample processing steps from the receipt of requisitions to the delivery of patient reports, and the ability to work independently in a dynamic, cross-functional team environment.
The Senior Clinical Laboratory Quality Assurance Analyst will interact with many different functions including Accessioning, Customer Service, the Analytical and Histology Laboratories, Pathology, Medical Affairs, Development, Process Engineering, Manufacturing/QC, and Biostatistics. Therefore, the Senior Clinical Laboratory Quality Assurance Analyst must demonstrate excellent customer service skills and the ability to effectively communicate across all levels of the laboratory and across departments.
RESPONSIBILITIES / DUTIES:
- Serve as the QA and Regulatory lead on cross functional teams, providing answers, decisions and recommendations on QA and Regulatory matters
- Lead and manage preparation for CAP, New York state and other inspections
- Manage the preparation and filing of complex regulatory submission such as for new products/assays
- Prepare and submit regulatory submissions including yearly license renewals and personnel forms
- Perform QA review of nonconformance and deviation reports
- Manage preparation of and lead QAI meetings
- Perform internal audits and document results of the audits
- Review and monitor laboratory data in process monitoring reports
- Train QA, Clinical Laboratory and support staff on QA procedures and regulatory requirements
- Independently identify and troubleshoot high complexity QA and Regulatory issues
- Assist with and ensure compliance with QA procedures and policies
- Provide QA assistance for resolution of technical problems and ensure that timely and effective remedial actions are taken whenever test systems deviate from the laboratory's established performance standards
- Provide QA and regulatory assistance when working with the laboratory leadership team on the laboratory's quality control and quality assurance procedures, technical troubleshooting and improvement procedures, and training and education programs
- Author QA and regulatory standard operating procedures and documents
- Perform QA review of standard operating procedures and certain protocols and technical reports
- Manage and/or participate in high complexity QA and Regulatory projects
- Assist with directing and guiding junior level QA and Regulatory staff in completion of tasks
- Serve as the QA Supervisor/Manager in his/her absence as needed
- Assist QA Supervisor/Manager with personnel related administrative duties
- Report all concerns of test quality and/or safety to the Supervisor or Safety Officer
- Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science or related field.
- At least two years of Clinical Laboratory experience and at least two years of relevant QA experience in a high-complexity Clinical - Laboratory or similar environment or Five years of relevant QA experience in a high-complexity Clinical Laboratory or similar environment.
- Demonstrated ability to lead and manage QA and Regulatory projects.
- Licensed California Clinical Laboratory Scientist preferred.
- Possess advanced working knowledge of local, state, and federal laboratory regulations.
- Ability to analyze and problem solve complex issues that may impact test performance.
- Strong analysis and problem solving skills.
- Strong technical skills and job and industry knowledge.
- Excellent writing skills.
- Ability to effectively communicate technical information to technical and non-technical audiences.
- Ability to proactively communicate consistently, clearly, and honestly.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT :
- Hours and days may vary depending on operational needs
- Standing or sitting for long periods of time may be necessary
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