Job Description

The QA/QC Manager will help the laboratory execute quality centric goals and objectives while constantly maintaining regulatory compliance for the laboratory that is CLIA Certified and CAP accredited. In addition to improving overall quality, you will serve in a coaching capacity for the operational leadership in the creation and implementation of processes, policies, and procedures. Must have cell culture experience.

· Establish and maintain QA/QC, and Safety programs in accordance with all regulatory standards.

· Annual review and update of all quality assurance/quality control, and safety documentation, policies, and procedures.

· Annually review for completeness of all personnel files only as it relates to those aspects required for accreditation, state/local licensure and certification including educational requirements, work resumes, certification, licensure, continuing education, competency, training, director delegations, health and safety requirements, compliance, etc.

· Annually participate in department budget preparation as directed.

· Assess the QA/QC data submitted by departments and prepare report summaries performed by the lab operations director.

Assess the validity of the results through the evaluation of QA/QC documentation.

· Performance of new method validations, implement new testing methods and/or instruments for testing site.

· Need to be accessible to testing personnel; at all times, testing is performed to provide on-site, telephone, or electronic consultation to resolve technical problems in accordance with policies and procedures established by the Laboratory Director.

· Maintain a close working relationship with the lab operations director, laboratory director, and other senior and executive leadership.

· Evaluate and assist with lean projects throughout the laboratory that improves overall processes to help the laboratory provide quality patient care in a cost effective and timely manner to its clients

· Perform other work-related duties as assigned.

Requirements:

· Bachelor’s degree in science or related subject, or Medical Laboratory Scientist (MLS) or equivalent with the American Society of Clinical Pathology or acceptable equivalent. 3-5 years’ experience in High complexity clinic lab certified by CLIA, as well as cell culture, required.

· Quality Assurance Certification preferred (ASQ, CMQ, etc.).

· 5-7 years in quality assurance is a plus.

· Clinical laboratory experience is required.

· Experience in document control establishment and maintenance.

· Highly proficient in Microsoft Excel.

This position is onsite.

This position is not remote or hybrid.

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