Clinical Laboratory Specialist Lead

Job Description Summary
Under minimal supervision and using independent judgment, 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.

Job Description

PRIMARY DUTIES AND RESPONSIBILITIES

• Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
• Maintains acceptable attendance and punctuality per the absence policy.
• Liaises with vendors and clients and provides direct customer service. Communicates with customers, vendors, and couriers to ensure quality service. Assures quality customer service to all customers.
• Assists with workflow coordination, trains and mentors staff, as required.
• Oversees and performs routine testing of biological samples. Ensures completion of reagent preparation, pre-qualification, and quality assurance. Maintains accurate records and documentation. Ensures donor, patient, and employee confidentiality. Reviews and ensures timely release of test results.
• Conducts required competency assessments and completes documentation. Takes appropriate corrective action as necessary. Provides routine and non-routine training to staff, as required, and ensures all training and/or re-training is documented.
• Makes recommendations to revise policies and procedures, as appropriate.
• Oversees the timely completion of survey and proficiency testing.
• Ensures and performs preventive maintenance, quality assurance and calibrations on equipment. Identifies and repairs more complex equipment malfunctions, performs trouble shooting and notifies appropriate personnel if additional service is needed.
• Ensures an adequate level of supplies and reagents are maintained.
• Ensures the cleanliness of equipment and work areas. Ensures safety guidelines are adhered to.
• Investigates deviations in testing, quality control and preventative maintenance. Is responsible for corrective action and escalates to appropriate management as necessary.
• Coordinates and performs evaluations of reagents, equipment, and new testing methods.
• Participates on process improvement teams.
• Performs all other duties, at the discretion of management, as assigned.

REQUIRED QUALIFICATIONS

• Education: Bachelor's or higher degree in Biology or Chemistry required, or science related degree where education and training meet CFR 493.1489.
• Must possess at least 1 year of clinical laboratory experience required To include: 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 required.
• Must possess demonstrated advanced clinical laboratory knowledge and competency so as to provide testing quality control, as well as 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

• Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.
• Must be able to maintain confidentiality.
• Must have analytical, statistical, personal organization, and problem-solving skills.
• Must have 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%

The above statements are intended to describe the general nature and level of work performed by people assigned to this job. They are not intended to be an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The job description reflects the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all the work requirements that may be inherent in the job. Creative Testing Solutions is an Equal Opportunity Employer.

Additional Job Details:

Shift 2

Saturday, Sunday, Monday 9:00 AM to 9:30 PM

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 View email address on click.appcast.io 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:

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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.