Job Description Summary
Under direct supervision a Clinical Laboratory Specialist (CLS) is responsible for performing routine high complexity testing of biological specimens. CLSs work in a team environment to ensure timely and quality test results. Clinical Laboratory Specialists must maintain required competencies for applicable testing.
Job Description
PRIMARY DUTIES AND RESPONSIBILITIES
Duties and responsibilities regularly performed by and assigned to CLS levels II III and IV:
- 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.
- Communicates with customers vendors and couriers to ensure quality service. Assures quality customer service to all customers.
- Performs routine testing of biological samples and notifies appropriate personnel of any identified problems. May assist with processing biowaste specimens and microplates.
- Maintains accurate records and documentation. Ensures donor patient and employee confidentiality. Performs document reviews as assigned.
- May pack and ship supplies and/or specimens. May receive and manage incoming supplies and reagents. Assists with lot changes as directed.
- Prepares labels verifies and performs prequalification of reagents. Ensures supply and reagent levels are at the appropriate levels and notifies appropriate personnel when new supplies are needed.
- Operates equipment and monitors for errors and responds appropriately. Performs routine preventive maintenance on equipment and identifies equipment malfunctions. Notifies appropriate personnel if additional service is needed.
- Resolves routine problems and escalates nonroutine issues when appropriate. Assists with problem investigation.
- Participates in performance improvement teams and training programs as required.
- Maintains the cleanliness of equipment and work areas. Adheres to safety guidelines.
- Performs all other duties at the discretion of management as assigned.
Additional duties and responsibilities regularly performed by and assigned to CLS levels III and IV:
- Serves as a resource for corrections and clarification.
- As appropriately delegated laboratory leadership:
- Analyzes prioritizes and resolves complex equipment or reagent problems. Investigates deviations in testing quality control and preventative maintenance.
- Recommends and implements corrective actions.
- Assists with competency documentation records review and records management.
- Assists with workflow coordination.
- Assists in reviewing results for proficiency survey sample testing.
- Escalates applicable issues to vendors and ensures appropriate followup and resolution.
- Provides mentorship and guidance to newer staff.
Additional duties and responsibilities regularly performed by and assigned to CLS level IVs:
- Trains newer staff.
- Liaises with vendors and clients and provides direct customer service.
- Performs equipment calibration and qualification. Identifies and repairs equipment malfunctions performs trouble shooting and notifies appropriate personnel if additional service is needed.
- Assists in coordination and performance of evaluations (e.g. reagents equipment new testing methods).
- Assists with performing required competency assessments as directed by laboratory leadership.
- As assigned may provide occasional backup and support to CLS Leads.
REQUIRED QUALIFICATIONS
- Education: Bachelors or higher degree in Biology or Chemistry required or science related degree where education and training meet CFR 493.1489.
- 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.
- CLS Levels III and IV:
- Must possess at least 1 year of clinical laboratory experience.
- 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.
- CLS Level IVs:
- Must have previous experience as a Clinical Laboratory Specialist at Creative Testing Solutions.
- 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 assist with staff competency assessments and training.
PREFERRED QUALIFICATIONS
- Trainer Certification preferred but required for CLS IVs in Plasma Services.
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 proficient computer skills.
- Ability to work in a team environment and participate as an active team member.
- Must be able to understand follow and give precise written and verbal instructions and perform all activities safely.
- Must be able to read and comprehend written procedures and instructions.
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
INTERNAL ADVANCEMENT STATEMENT
In order to be considered for advancement to the next CLS level employees must possess the required qualifications skills and abilities as stated in the job description AND regularly demonstrate the qualities and behaviors commensurate with our CTS mission vision and values as detailed in the Career Ladder document available on the SharePoint Portal.
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 3
Friday to Monday 8:00 PM to 6:30 AM
Training Schedule for 46 months Monday to Thursday 2:00 PM 12:30 AM
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 email to 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
EEO is the Law Supplement
Pay Transparency
eVerify
All candidates who receive a conditional written offer of employment will be required to undergo a preemployment drug test in accordance with the Companys established guidelines.