Irvine, CA

September 2, 2020

Location: Irvine, CA

Department: Laboratory Operations

Reports To: Manager, Laboratory Operations

FLSA Status: Non-Exempt

 

 

Job Summary:

The CLS works under minimal supervision and is responsible for complex molecular diagnostic testing laboratory procedures using all types of qualified specimens submitted for testing.

Essential Duties and Responsibilities:

Laboratory Activities:

  • Exceptional knowledgeable of all techniques involving DNA/RNA extractions, PCR and RT-PCR reactions, DNA sequencing and other molecular genetic techniques
  • Considered by the CLS I staff as a resource for microarray technology, such as, labelling RNA, hybridizing, washing and scanning microarrays
  • Perform diagnostic laboratory activities on the basis of standard operating procedures
  • Compose and revise Standard Operating Procedures (SOP’s) under the direction of the Lab Director, Lab Ops Director or Lab Manager.
  • Consults with the Lab Director, Lab Ops Director or Lab Manager regarding the daily work flow of the clinical laboratory and troubleshooting
  • Performs all aspects of laboratory procedures following safety guidelines and adhering to protocols as it pertains to Agendia, Inc.’s health and safety policies and procedures
  • Responsible for assigned projects (instrument comparisons, instrument calibrations, staff schedules, process improvement, lab training and competency, assay or instrument validation, etc.)
  • Performs other related duties as required or assigned in the laboratory

Post Analytic:

  • Maintain a filling system (paper or electronic) for completed patient data
  • Register results and data in lab journal and LIMS
  • Assist other personnel and departments when requested

Professional:

  • Initiate own career development by being familiar with current literature, seeking out seminars, workshops and other professional meetings relating to professional field.
  • Adhere to various federal and state laws, regulations and guidelines (e.g. California labor laws, OSHA, CLIA, College of American Pathologist, New York State Department of Health, GLP, GCP, HIPAA, ISO 13485, and other as applicable).
  • Exhibit ethical and professional behavior at all times.
  • Maintain patient confidentiality at all times.

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.

Contacts:

  • This position may interact with all departments within the company as well as outside vendors and regulatory agencies.

Education and Experience Requirements:

  • At least a Bachelor’s degree required
  • 6+ years clinical laboratory experience with a Bachelor’s degree and 4+ years clinical lab experience with a Master’s degree, or 2+ years clinical lab experience with a doctoral degree.
  • Must have experience with molecular diagnostic techniques, histology techniques, working with databases, microarray analysis, working with quality systems and lab automation and statistical analysis and/or software.

Certificates and License Requirements:

  • California Clinical Laboratory Scientist (CLS) or Clinical Genetic Molecular Biologist Scientist (CGMBS) License or any other specialist license that can perform high complexity molecular testing.

Skills and Qualifications Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions.

  • Must have an exceptional understanding of general laboratory techniques and medical terminology with emphasis for the department specific techniques.
  • Ability to demonstrate a high level of initiative, balanced assertiveness and team orientation.
  • Ability to demonstrate excellent time management skills.
  • Ability to handle biological samples and potentially hazardous chemicals.
  • Ability to operate equipment with proficiently to successfully execute test procedures.
  • Computer skills and laboratory automation knowledge.
  • Exceptional ability to communicate effectively and follow written and verbal instructions.
  • A CLS II must be on-site during testing procedures.

Supervisory Responsibilities:

  • This position requires no formal supervisory responsibilities.

Environment/Safety/Work Environment:

  • General office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Maintains a clean, neat, and orderly work area.
  • Adheres to Department Specific Safety Guidelines.
  • In the absence of the Laboratory Director, Lab Ops Director or Lab Manager, a CLS II must be on-site during testing procedures.

Physical Demands:

  • Standing, sitting, walking, bending, reaching, manual manipulation, and lifting up to 15 pounds.
  • All candidates must take a color vision test.

ACKNOWLEDGMENT:

I have read and understand the above-mentioned job description. I will carry out my duties as outlined above. Affixed is my signature below as acknowledgment.