• Monitor and ensure compliance with operational processes and procedures.• Identify and mitigate potential compliance risks through strategic planning and implementation.• Develop and implement internal company policies and strategies.• Coordinate compliance with Clinical Laboratory Improvement Amendments (CLIA).• Train staff on laboratory procedures and compliance protocols.• Conduct competency assessments and oversee quality assurance and control systems.• Resolve technical issues and deviations, implementing corrective actions to maintain test system reliability.• Maintain comprehensive records and managed lab operations to support compliance and efficiency.• Assist in FDA submissions and investigations of quality issues.• Assist in validating clinical chemistry, molecular biology, & immunology assays for CLIA regulations• Isolate peripheral blood lymphocytes under sterile conditions

• Quality Control: Reviewed daily test data for compliance with quality control standards.• Data Verification: Analyzed lot testing and proficiency test results to ensure accuracy.• Competency Assessments: Evaluated laboratory staff performance and adherence to protocols.• Issue Resolution: Investigated assay and proficiency test failures, implementing corrective measures.• SOP Management: Established and updated SOPs to improve laboratory operations.

• Technical Support: Supported specimen handling, processing, and testing in clinical labs.• Proficiency Testing: Contributed to calibration verification and proficiency testing processes.• Antibody Purification: Utilized various techniques for antibody purification.• Assay Validation: Assisted in validating clinical assays for accuracy and reliability.• Inventory Management: Developed a system to streamline laboratory operations.• Training & Analysis: Trained staff on new assays and performed statistical analyses using advanced software.

• Immunoassays: Conducted various assays, including ELISA and RIA, to support diagnostics.• System Maintenance: Calibrated and operated automated laboratory systems.• Quality Control: Ensured accuracy and reliability through quality control checks and sample processing.