Job Description

We are seeking a highly skilled and detail-oriented QA/QC Manager to oversee quality assurance and quality control processes within a medical testing laboratory. The ideal candidate will possess extensive knowledge of CLIA/CAP regulatory standards, ensuring that all laboratory operations meet stringent quality requirements. As QA/QC Manager, you will lead the development, implementation, and continuous improvement of quality systems to uphold the highest standards of accuracy, safety, and compliance. This role offers an exciting opportunity to influence laboratory excellence and ensure reliable testing outcomes in a dynamic healthcare environment.

Major Duties and Responsibilities

· Develop and maintain comprehensive quality management systems aligned with CLIA/CAP regulations.

· Identify training needs and ensure everyone performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed.

· Maintain and establish a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results.

· Resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.

· Evaluate the competency of all testing personnel and ensure the staff maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to;

· Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing.

· Monitoring the recording and reporting of test results.

· Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.

· Direct observation of performance of instrument maintenance and function checks.

· Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.

· Assessment of problem-solving skills.

· Lead internal and external quality audits to verify compliance with regulatory requirements and industry best practices.

· Oversee quality inspection procedures across all laboratory processes to identify areas for improvement and ensure adherence to specifications.

· Manage documentation control, including validation protocols, calibration records, and audit reports to support regulatory submissions.

· Coordinate with laboratory management and staff to implement robust quality control measures that ensure the accuracy and reliability of test results.

· Conduct root cause analysis for non-conformances and implement corrective and preventive actions (CLIA) to mitigate risks.

· Evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation.

· Provide leadership in training staff on quality systems, regulatory updates, and best practices in laboratory operations.

· Drive continuous improvement initiatives by analyzing data trends and integrating new methodologies into existing quality frameworks.

· Perform various additional duties, as required and necessary for effective business operations.

Job Specifications

· 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.

· RSO Certificate.

· Quality Control/Quality Assurance certifications preferred (ASQ, CMQ, etc.).

· 5-7 years in quality control and quality assurance is required.

· Previous laboratory management experience is required.

· Clinical laboratory experience is required.

· Experience working and communicating with all levels within an organization.

· Experience in document control establishment and maintenance.

· Highly proficient in Microsoft Excel.

· Must adhere to all HIPPA regulations, OSHA and CLIA rules and regulations for laboratories including use of PPE.

· The ability to multitask and manage daily changes in workflow with flexibility and good judgement.

· The ability to work in a changing team environment, as well as independently, with efficiency, accuracy, and professionalism.

· The ability to be meticulous, with high attention to detail.

· Must be flexible and willing to work in areas and on problems that may not normally be part of the position but required for the efficient operation of the business.

· Proven experience in quality assurance and quality control within a medical testing laboratory or related healthcare environment.

· Strong understanding of CLIA/CAP standards for medical testing.

· Demonstrated ability to conduct thorough quality audits and manage complex projects effectively.

· Excellent analysis skills with a focus on problem-solving and process optimization.

· Knowledge of manufacturing processes related to medical testing equipment or consumables is advantageous.

· Exceptional organizational skills with attention to detail in documentation and compliance activities.

· Effective communication skills to collaborate with cross-functional teams and regulatory bodies.

Join us as we uphold the highest standards of quality assurance in medical testing laboratories—ensuring accurate diagnostics that improve patient outcomes worldwide!

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