QA/QC Manager

Company Description

SpectraCell Laboratories, Inc. is a leading provider of advanced intracellular nutritional testing and precision diagnostics at the cellular level. Founded on nutritional analysis, SpectraCell has expanded to offer innovative solutions that address key aspects of health, including cellular nutrition, cardiovascular health, and genetic predisposition. With a strong commitment to quality service and patient care, SpectraCell supports healthcare providers nationwide. The company is dedicated to advancing healthcare opportunities by delivering cutting-edge testing technologies. For more details, visit SpectraCell Laboratories.

Role Description

This is a full-time, on-site position located in Houston, TX. 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. Also responsible for the technical and scientific oversight of the laboratory.  

Technical Supervisory Responsibilities:

• Verify the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system.
• Oversee the daily QA/QC processes of the laboratory departments.
• Selection of the test methodology that is appropriate for the clinical use of the test results.
• 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.
• Ensure patient test results are not reported until all corrective actions have been taken and the test system is functioning properly.
• 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.
• 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.
• 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.

Duties/Responsibilities:

• Establish and maintain Quality Assurance/Quality Control, 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.
• 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 once every quarter.
• Participate in department budget preparation yearly.
• Assess the quality assurance and quality control data submitted by departments and preparation of report summaries performed by the Laboratory Operations Director.
• Assess the validity of the results through the evaluation of quality assurance and quality control documentation.
• Performance of new method validations, implement new testing methods and/or instruments for testing site.
• Need to be accessible to laboratory personnel; at all times, testing is performed 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 laboratory director and other senior level/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.
• 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.
• Must have experience with health industry regulations (e.g., CLIA, CAP) - Required.
• Quality Assurance/Quality Control certifications preferred (ASQ, CMQ, etc.).
• 5-7 years in quality assurance and quality control in a medical laboratory setting.
• 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.