Lab QA/QC Coordinator

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

Specific Duties and Responsibilities

• Maintain laboratory licensure and accreditation (CLIA, CAP, 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.
• Review, maintain and update standard operating procedures annually and as needed.
• 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 complement 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.
• Assist with annual competency assessments.

Special Knowledge, Skills, and 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.

Specific Physical Requirements

• While performing the duties of this job, the employee is regularly required to sit, talk, see and hear. May sit or stand for prolonged periods and occasionally required to walk. The employee is frequently required to use hands to finger, touch, feel, and type. May reach with hands and arms; stoop, kneel, or crouch. Prolonged vision requirements including viewing computer screens, paper reports/documents, charts, and results.
• Visual acuity is required to distinguish fine gradation of color or structure and closely examine specimens microscopically. Must possess manual dexterity sufficient to work with small instruments and delicate equipment.
• Clinical laboratory environment - Exposure to toxins and infectious agents exists, but potential for personal injury or harm is minimized if established safety and health precautions are followed. Working in a laboratory where there may be discomforts due to odors, noise, temperature fluctuations, and working around lab equipment.
• May transport equipment and supplies usually less than 40 pounds from one area to another. May be required to lift and/or move up to 50 pounds with proper training or precautions/lifting aides.
• In some areas, workspaces are confined; therefore mobility may be difficult.
• Staff may be required to complete annual competency reviews and must ensure compliance with Hospital Policy, Laboratory Policy & Procedure, Health, Safety & Environment regulations, and all applicable privacy & confidentiality laws/practices.
• Must be detail-oriented, organized, and accurate.
• Many department laboratories operate 24/7 with schedules on day, evening, or night shifts. Rotating schedules may include weekend work and holiday assignments. Overtime possible when authorized/needed to meet business and patient needs.
• While most positions require on-site presence; where positions are approved for alternate work locations (remote work) - specific expectations will be outlined and documented; and the safety of the work environment, security of work information, and productivity measures are regularly reviewed with employees and subject to ongoing approval by management. Staff should be aware of and report other remote work implications and requirements that may impact them or the organization.

Minimum Qualifications

• Bachelor's degree in medical technology or a related science (Clinical Laboratory Science, Biology, Chemistry, etc.).
• Four years of clinical laboratory or quality compliance experience.

Preferred Qualifications

• Post-graduate degree in a relevant area.
• Professional certification is preferred (e.g., CQA, Six Sigma, CQM).