Director of Clinical Laboratory Services

Seeking a Director of Clinical Laboratory Services for a Direct Hire role in Cleveland, OH.

Essential Duties and Responsibilities:

• Responsible for the technical and scientific oversight of the laboratory including testing personnel and personnel reporting test results
• Develops and maintains department objectives and services
• Develops and updates policies and procedures to ensure compliance withs CAP and CLIA Guidelines
• Plans, organizes, and directs staffing including activities related to hiring, scheduling, evaluating, and continuing education
• Prepare annual operating and capital budgets
• Completes all tasks/assignments delegated by the Medical Director
• Develops and implements contingency plans to avert possible interruptions in services due to technical or mechanical issues
• Responsible for the accuracy of all tests performed within the CLIA Lab. Ensures quality of testing through review of quality control data and test results. Responsible for the accuracy of reference ranges within the lab
• Assures competency of all technical staff utilizing the CLIA defined competency elements
• Ensures technical proficiency of staff and self through the participation of internal competencies (technical and computer) and external proficiency testing programs
• Assures testing is in accordance with production schedule and that variances from schedule are identified, resolved and communicated to the Laboratory Director in a timely manner
• Downtime exceptions (instrumentation) are communicated to appropriate staff within a timely manner
• Demonstrates competency in statistical analysis, quality control review and instrument linearity/correlations
• Communicates with physicians and clinicians on patient care issues
• Responsible to communicate (inform and get input from) procedural issues with the Medical Director
• Implements the standard of CAP, CLIA and other pertinent accrediting agencies
• Assist in the implementation of and participates in an effective Laboratory Performance Improvement Program
• Promotes participation among technical and support staff in Performance Improvement activities; empowers Laboratory staff to assist with problem resolution
• Adheres to the company’s quality control policies; documents all quality control activities including calibrations and maintenance performed. May develop and implement additional quality control policies and documents to support product development. 
• Maintains instruments and equipment in accordance with manufacturer’s specifications
• Maintains clear and legible records
• Plans, organizes, performs, and monitors daily project activities
• Responsible for materials management including effective utilization of supplies and monitoring of inventory to maintain suitable stock

Qualifications:

• BA/BS in Chemical, biological or clinical laboratory science
• Master of Health Administration (MHA) or Business Administration (MBA) preferred
• MT (ASCP) or MLS (ASCP) certification
• Five years of experience working in a High Complexity clinical or CLIA lab environment with at least 5 years management experience
• Experience operating and maintaining Roche cobas e411 and/or 6000 clinical chemistry and immunoassay analyzers preferred
• Experience working with and/or developing ELISA assay preferred
• Understands and complies with good laboratory practices, including safety, HIPPA, confidentiality and regulatory requirements
• Requires critical thinking skills and decisive judgement skills with excellent attention to detail 
• Must be a self-starter with high motivation level and eagerness to learn
• Excellent aptitude for troubleshooting laboratory equipment
• Effective interpersonal, organizational and communication skills required
• Excellent computer skills with proven proficiency in Microsoft Office products including Word and Excel

Physical Requirements: 

Work involves a fast-paced laboratory environment with a moderate amount of walking, standing, and/or sitting with occasional light lifting. Fine motor skills and manual dexterity to handle specimens, lab equipment and operating a computer. Work is performed in general laboratory environment, possible exposure to bloodborne pathogens and hazardous chemicals requiring the use of personal protective equipment. Offices reachable by elevator but should be able to climb stairs in case elevator out.