Clinical Laboratory Specialist Lead

Creative Testing Solutions; St. Louis (MO); On-site; USD 85,000 - 110,000; Full time

Job summary

Creative Testing Solutions is seeking a Clinical Laboratory Specialist Lead to perform routine and complex testing of biological specimens under minimal supervision. You will review quality data, provide technical support, and mentor staff while maintaining compliance with SOPs and CLIA/certifications.

You will coordinate workflow across the laboratory, ensure timely test result release, and participate in proficiency testing and equipment maintenance.

Qualifications

• Bachelor's or higher degree in Biology or Chemistry required, or science-related degree meeting CFR 493.1489.
• At least 1 year of clinical laboratory experience, including 1 year in workflow coordination.
• CLIA High Complexity Testing competency required by SOPs and regulatory bodies.
• State licensure or certificate where applicable and required.
• Demonstrated advanced clinical lab knowledge and proficiency for quality control and staff training.

Responsibilities

• Perform duties in compliance with SOPs and regulations.
• Provide skilled technical support in the laboratory and mentor staff.
• Oversee routine testing of biological samples and ensure quality results.
• Coordinate workflow and collaborate with vendors/clients for service quality.
• Conduct competency assessments and maintain complete documentation.
• Lead process improvement efforts and implement corrective actions as needed.

Skills

Confidentiality

Analytical skills

Problem-solving

Communication skills

Education

Bachelor's degree in Biology or Chemistry

Job description

Job Description Summary

Under minimal supervision and using independent judgement, this position is responsible for performing routine testing of biological specimens and reviewing test results and quality assessment data in accordance with all applicable guidelines and procedures. This position is also responsible for providing skilled technical support in the laboratory. Incumbents will participate in the administrative and workflow coordination functions of the laboratory. Clinical Laboratory Specialist Leads must maintain required competencies for applicable testing.

Primary Duties and Responsibilities

• Perform all assigned duties in compliance with internal SOPs and external regulations.
• Bring compliance issues to the attention of management.
• Maintain acceptable attendance and punctuality per the absence policy.
• Liaise with vendors and clients and provide direct customer service.
• Communicate with customers, vendors, and couriers to ensure quality service.
• Assure quality customer service to all customers.
• Assist with workflow coordination, train and mentor staff as required.
• Oversee and perform routine testing of biological samples.
• Ensure completion of reagent preparation, pre‑qualification, and quality assurance.
• Maintain accurate records and documentation.
• Ensure donor, patient, and employee confidentiality.
• Review and ensure timely release of test results.
• Conduct required competency assessments and complete documentation.
• Take appropriate corrective action as necessary.
• Provide routine and non‑routine training to staff, as required, and ensure all training and/or re‑training is documented.
• Make recommendations to revise policies and procedures as appropriate.
• Oversee the timely completion of survey and proficiency testing.
• Ensure and perform preventive maintenance, quality assurance and calibrations on equipment.
• Identify and repair more complex equipment malfunctions, perform troubleshooting and notify appropriate personnel if additional service is needed.
• Ensure an adequate level of supplies and reagents are maintained.
• Ensure the cleanliness of equipment and work areas.
• Ensure safety guidelines are adhered to.
• Investigate deviations in testing, quality control and preventative maintenance.
• Be responsible for corrective action and escalates to appropriate management as necessary.
• Coordinate and perform evaluations of reagents, equipment, and new testing methods.
• Participate on process improvement teams.
• Perform all other duties, at the discretion of management, as assigned.

Required Qualifications

• Education: Bachelor’s or higher degree in Biology or Chemistry required, or a science‑related degree where education and training meet CFR 493.1489.
• Must possess at least 1 year of clinical laboratory experience, including at least 1 year of workflow coordination experience.
• CLIA requirements for High Complexity Testing required.
• California testing requirements where required by law or SOP.
• Appropriate state licensure and/or certificate, where applicable, required.
• Must possess High Complexity Testing competencies required by Standard Operating Procedures (SOPs), CLIA, and other applicable regulatory and accrediting bodies.
• Must possess demonstrated advanced clinical laboratory knowledge and competency to provide testing quality control, as well as provide proficient training and guidance to newer staff.
• Must possess demonstrated proficiency of complex equipment and reagent maintenance for troubleshooting and problem resolution.
• Advanced proficiency must be demonstrated with all equipment at the assigned location.
• Must possess demonstrated understanding of, and experience with, proficiency survey sample testing.
• Must possess demonstrated equipment calibration and qualification proficiency for all equipment at the assigned location.
• Must possess advanced clinical laboratory competency expertise that meets regulatory and SOP requirements, so as to conduct staff competency assessments and training.

Preferred Qualifications

• Trainer Certification preferred, but required for CLS Leads in Plasma Services.
• MT, ASCP (or equivalent) Specialty Certification preferred.

Skills and Abilities

• Maintain confidentiality.
• Analytical, statistical, personal organization, and problem‑solving skills.
• Proficient computer skills.
• Ability to think strategically and independently.
• Effective oral and written communication skills.
• Ability to establish priorities and follow through on projects, paying close attention to detail with minimal supervision.
• Able to organize, prioritize, and execute a variable workload and multiple priorities.

Physical & Travel Requirements

5+ hours per shift: Sitting, Standing, Handling, Finger dexterity, Pinching.

3–5 hours per shift: Lifting to 40 pounds.

Up to 3 hours per shift: Walking, Climbing, bending, squatting, reaching above shoulders, reaching waist to shoulder, reaching knee to waist, reaching floor to knee, grasping items, carrying/move items up to 40 pounds.

Travel: <5% of time.

EEO Statement

Creative Testing Solutions is an Equal Opportunity Employer. Creative Testing Solutions is an equal opportunity employer. EEO/Minorities/Females/Disabled/Veterans. Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e‑mail to [e-mail] to let us know the nature of your request. A representative will respond to accommodation requests within two business days. Please note that this email/phone number is for medical/disability accommodations only and any other inquiries will not receive a response. Please see the below information about applicant rights and our commitment to compliance: EEO is the Law. Supplement Pay Transparency e-Verify.

All candidates who receive a conditional written offer of employment will be required to undergo a pre‑employment drug test in accordance with the Company's established guidelines.