Sr. Clinical Lab Scientist

Location
San Diego, California, United States
Posted
Oct 06, 2020
Ref
oe6HdfwY
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
SUMMARY Performs pre-analytical and analytical testing, interprets and reports patient results to ordering physicians.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
  • Responsible for quality control, testing and reporting of laboratory test results for all test methods approved by CAP, NY and CLIA
  • Organizes patient specimen and assay worksheets for testing and monitors WIP
  • Provides direct and constant guidance to Clinical/Medical Laboratory Technicians as required by applicable state and federal regulations
  • Evaluates performance of assay and quality control parameters, recommends corrective action(s) to laboratory management, and re-evaluate standards/controls
  • May act as a designee in the absence of the Team Lead including releasing holds, attending Quality Control/Quality Improvement meetings, acting as a liaison to Client Services, and scheduling shifts
  • Maintains schedule for Analytical Measurement Range, Calibration/Verification, and Linearity and ensures that they are performed
  • Submits sample request to Corporate Biobank
  • Actively provides input for process design and improvement activities
  • May participate in cost analysis projects
  • Assists with the implementation of new test methods from Research or external sources
  • May act as departmental representative for cross-functional projects
  • Assists with and may coordinate technical studies designed to improve or validate clinical laboratory testing methods
  • Performs testing on clinical study samples as needed
  • Monitors equipment preventative maintenance schedule with Metrology and vendors, ensures that OOS sticker is on equipment, and parallel assays are performed on equipment
  • Performs qualification on materials and/or instruments used in laboratory operations, ensures material qualification is completed in a timely manner, completes qualification paperwork, and initiates/investigates out of specification and nonconforming material reports
  • May perform direct observation for competency assessment (including pipette competency assessment) of Clinical/Medical Laboratory Technicians and Clinical Laboratory Scientists
  • Monitors reagent and supply inventory and initiates Materials Disposal Form
  • Reviews preventative maintenance records and service reports
  • Performs/reviews preventative maintenance and calibrations on laboratory equipment
  • Performs technical review of Laboratory Batch Records
  • Prepares laboratory reagents and assay materials according to Standard Operating Procedures
    • Writes/revises laboratory documents such as Standard Operating Procedures and laboratory forms
    • Required to follow all safety procedures, Standard Operating Procedures, Equipment Operating Procedures and policies
    • Assists with CAP and NY state inspections and self-inspections
    • Provides training to other laboratory personnel

    SUPERVISORY RESPONSIBILITIES This job has no supervisory responsibilities.

    QUALIFICATIONS 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 enable individuals with disabilities to perform the essential functions.

    EDUCATION and/or EXPERIENCE Position generally requires a Bachelors degree, advanced degree preferred and 8+ years' related experience. Current California CLS license required. Experience working in a high complexity CLIA/CAP environment preferred. Data entry and Microsoft office skills strongly preferred. Previous experience providing guidance and direction to other laboratory personnel highly preferred. Previous experience managing projects preferred.

    LANGUAGE SKILLS Ability to read and interpret documents such as scientific publications, vendor specifications, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Strong interpersonal skills and ability to work cross-functionally. Ability to understand and comply with all applicable laboratory regulated guidelines. Ability to effectively communicate and collaborate with internal and external customers.

    MATHEMATICAL SKILLS Ability to work with mathematical concepts up to probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to read and analyze financial data.

    REASONING ABILITY Ability to define problems, collect data, establish facts and draw reasonable conclusions. Ability to interpret a variety of technical instruction in mathematical or diagram form. Ability to understand and comply with all applicable laboratory regulated guidelines. Ability to understand and utilize project management tools. Ability to evaluate new technologies and make recommendations as appropriate to lab operations.

    CERTIFICATES, LICENSES, REGISTRATION Current California CLS license required. Must maintain continuing education units required by California Department of Health Services.

    PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    While performing the duties of this job, the employee is regularly required to sit for extended periods of time in front of a computer monitor. The employee is frequently required to use hands to finger, handle, or feel.

    The employee frequently is required to stand walk, sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

    WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and extreme cold.

    The noise level in the work environment is usually moderate with background sounds from instruments and freezers.