Lab QA/QC Coordinator

The Pathology Department is seeking a Lab QA/QC Coordinator who under the supervision of the Laboratory Manager will be responsible for planning, coordinating and overseeing all of the functions within the scope of Quality Systems, including the Quality Control and Quality Improvement Programs, Quality audits, and obtaining and maintaining all accreditations to ensure that services are of the highest quality.

Specific Duties & Responsibilities

• Maintain laboratory licensure and accreditation (CLIA, ASHI, NYS) through periodic renewals, new applications, method submissions and managing the proficiency testing program.
• Serve as the liaison between the clinical laboratory and accrediting agencies.
• Administer and manage the document control system, incident reporting system and personnel documentation
• Review all laboratory procedures and validation documentation for compliance following regulation and guidance
• Assure proper qualification of laboratory personnel according to regulatory standards.
• Perform regular internal quality audits in all laboratory sections; follow up with recommendations, corrective, and preventive actions as needed.
• Identify procedural and systemic compliance risks and recommend continuous improvements that complements existing practices.
• Review and follow up on non-conformances, deviations until resolution. Initiate corrective and preventative actions to address system deficiencies and drive implementation of corrective action plans.
• Oversee and manage quality system related meetings, collect and trend key performance indicators.
• Interface and collaborate with laboratory personnel to educate, provide training, and ensure compliance in all aspects of the clinical process.
• Serve as the Laboratory Safety Officer.

Special Knowledge, Skills & Abilities

• Excellent communication, computer and writing skills.
• Work produced is subject to precise measure of quantity and quality. Attention to detail is critical to the successful performance of this job as it directly affects patient outcomes.
• Knowledge of good lab practices and academic medical center & research environments, general medical terminology. Regulatory standards.
• Ability to perform tasks on computer and assigned systems at appropriate level for the job. For example, use of MS Office, email, phones, handheld devices; Pathology, JHM, and Hospital data & patient systems.
• Ability to operate assigned equipment, troubleshoot and follow standard operating procedures.
• Maintains accurate, organized, detailed, clear & concise work documentation, records/logs, written communication. Maintains a clean and safe working environment.

Physical Requirements

• While performing the duties of this job, the employee may remain in a stationary position (sitting) up to 60% of the time and standing/walking at 40%. Occasionally required to traverse throughout the laboratory or to retrieve equipment, supplies, or specimens from other locations on campus. The employee is required to operate computer keyboard, laboratory instruments, and small laboratory tools such as pipettes, cutting instruments, glass tubes, dishes, and/or slides. Constantly repositions self to perform duties at laboratory workstations, gathering specimens, and loading equipment.
• The employee is required to use hands/fingers to touch, type and/or feel. Will operate computer keyboard, and/or laboratory instruments, small laboratory tools such as pipettes, cutting instruments, glass tubes, dishes, and/or slides.
• Prolonged vision requirements including viewing computer screen, paper reports/documents charts and results. Visual acuity is required to distinguish fine gradation of color or structure and closely examine specimens (including via a microscope) for laboratory positions.
• Position is primarily in a laboratory environment where exposure to toxins and infectious agents exist, but potential for personal injury or harm is minimized if established safety and health precautions are followed for assigned work areas. Must refer to and are expected to comply with procedure manuals, follow proper laboratory protocols and safety policy/procedures, and be familiar with material data safety sheets in assigned work areas. Able to read and understand all Health, Safety and Environment (HSE) guidelines applicable to assigned work area. Working in laboratory where there may be discomforts due to odors, noise, temperature fluctuations, and working around lab equipment. Research areas may include animal, human, human products, DNA, and radiation protocols. Clinical Research and patient care duties may require direct interaction with patients at all levels of health or illness; including those