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Clinical Testing Resume Profile

Quality Professional

Highly-skilled Quality Professional with solid and proven knowledge and experience in complaint investigations, process and product improvement and auditing, technical writing and training, and informative presentation skills relative to medical settings. Certified Medical Technologist 137636 October 1980 , Specialist in Lab Safety 123 and Diplomate in Laboratory Management 509 by ASCP. Designated a Certified Laboratory Consultant by AMT. Expert knowledge of CLIA, OSHA, JCAHO, CAP, FDA, AABB, and other federal regulatory requirements. 30 years of technical writing and reporting. Core competencies:

Quality Assurance

CLIA/OSHA/JCAHO/CAP

Performance Management

FDA/ISO Compliance

Process Improvement

Public Speaking

Technical Communications

Training Program Development

Strategic Planning

Confidential

Product Complaint Specialist

Entry, investigation, processing and closing of product complaints for worldwide medical device company determination of reportability, adhering to Food and Drug Administration FDA and Health Canada requirements. Evaluated complaints for medical device reportability, developing justification using laboratory knowledge and FDA guidances. Created presentations for training in Regulatory and Quality Assurance. Worked with cross-functional teams to develop appropriate investigations and CAPAs for improvement of technical, IT, reagent and delivery issues. Worked extensively with Technical Services, Field Service, and reagent manufacturing for investigations. Performed audits of compliance and ethics, technical, IT and reagent areas as part of quality system.

Confidential

Medical Technologist

Conducted chemical analysis of body fluids, including blood, to determine presence of normal and abnormal components. Analyzed samples of biological material for chemical content or reaction. Performed complex medical laboratory tests for diagnosis, treatment, and prevention of disease. Developed, standardized, and evaluated procedures, techniques, and tests used in the analysis of specimens and in medical laboratory experiments. Entered data from analysis of medical tests and clinical results into computer for storage. Established and monitored programs to ensure accuracy of laboratory results.

Key Accomplishments

  • Obtained, stained, and mounted biological material on slides for microscopic study and diagnosis, following standard laboratory procedures.
  • Operated, calibrated, maintained and performed troubleshooting on equipment used in quantitative and qualitative analysis as a generalist, alternating between blood bank, hematology, chemistry, urinalysis, and serology.

Confidential

Worked for institutions of varying sizes and complexities, providing technical support during recruitment and training of permanent employees, mainly in the Midwest. Performed clinical testing in all laboratory areas with minimal training on all shifts. Contributed regulatory and writing consultation. Created, revised and improved standard operating procedures, developed documentation recording logs, implemented safety training and documentation. Served as Technical Supervisor of military blood donor center, working with officers to adequately train soldiers.

Confidential

Technical Supervisor/Manager, Clinical Testing

  • Maintain accurate computerized record management systems to store and process data such as personnel activities and patient information, and to produce relevant reports. Expand and implement training programs that promote high quality work in research, rehabilitation, and community health. Conduct recruitment, hiring and training of personnel. Establish objectives and evaluative or operational criteria for clinical unit. Develop work schedules and staff assignments, according to workload, space, and equipment availability. Encourage communication between governing boards, medical staff, and department heads by attending meetings and coordinating interdepartmental functioning. Strictly enforce ACL and Aurora Health Care policies and procedures and creation of new policies and procedures to comply with changing regulatory
  • requirements. Evaluate testing methods for technical quality and business efficiency. Validate and implement new testing methods/instrumentation. Oversight for Transfusion Services, Clinical and Immunochemistry and Hematology.

Key Accomplishments

  • Inspect facilities and recommend equipment modifications in 22 hospital/80 clinic system to ensure emergency readiness and compliance to access, safety, and sanitation regulations.
  • Maintain awareness of advances in medicine, computerized diagnostic and treatment equipment, data processing technology, government regulations, health insurance changes, and financing options.
  • Manage change in integrated health care delivery systems, such as work restructuring, technological innovations.
  • Project manager for beta testing of combination hematology/hemoglobin A1c analyzer coordinating efforts of technical, IS, facilities, customer service staffs within Aurora and Advocate systems and instrument manufacturers.

Confidential

Clinical Laboratory Scientist

Conducted chemical analysis of body fluids, including blood, to determine presence of normal and abnormal components. Analyzed samples of biological material for chemical content or reaction. Performed complex medical laboratory tests for diagnosis, treatment, and prevention of disease. Developed, standardized, and evaluated procedures, techniques, and tests used in the analysis of specimens and in medical laboratory experiments. Entered data from analysis of medical tests and clinical results into computer for storage. Established and monitored programs to ensure accuracy of laboratory results.

Key Accomplishments

  • Obtained, stained, and mounted biological material on slides for microscopic study and diagnosis, following standard laboratory procedures.
  • Operated, calibrated, maintained and performed troubleshooting on equipment used in quantitative and qualitative analysis as a generalist, alternating between blood bank, hematology, chemistry, urinalysis, and serology.

Confidential

Technical Specialist

Provided consultation to pathologists, laboratory directors, managers and supervisors, respiratory therapists and nursing personnel preparing for inspection and recommended improvements in quality assurance and control, personnel management, operational training, safety, and regulations, including those of OSHA, FDA, CDC, AABB. Inspected numerous clinical laboratories including hospital, clinic, reference, transfusion medicine and donor service for LAP, FUDT, and ADT programs. Generated comprehensive reports for oversight committees.

Key Accomplishments

  • Designed PowerPoint inspector training presentations covering Laboratory Safety and other disciplines for CAP/ASCP, AACC, CAP regional meetings, and Veterans Administration national meetings.
  • Prepared written communication for accreditation program directors, physician commissioners, participants, resource committee members clarified LAP, CLIA, JCAHO requirements.
  • Worked on development, testing, training and implementing new software to document accreditation activities.
  • Staffed Environmental Health and Safety Resource Committee, with expertise in regulatory requirements: OSHA, NFPA worked on revisions to NCCLS GP-17, Laboratory Safety.

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