Clinical Lab Scientist II

Location
San Diego, California, United States
Posted
Jan 06, 2021
Ref
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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
  • Provides direct and constant guidance to Clinical/Medical Laboratory Technicians as required by applicable state and federal regulations
  • Assists with technical studies designed to improve or validate clinical laboratory testing methods
  • Performs testing on clinical study samples as needed
  • Reviews and maintains quality control records and reports all problems to laboratory management as required
  • Performs materials preparation and qualification on materials and/or instruments used in laboratory operations
  • May evaluate performance of assay and quality control parameters and recommends corrective action(s) to laboratory management
  • Assists with advanced troubleshooting issues involving equipment and assay performance
  • Performs preventative maintenance and calibrations on laboratory equipment
  • Assists with training other laboratory personnel
  • May initiate and provide input during process design and improvement activities
  • May assist with the implementation of test methods from Development or external sources
  • May perform direct observation for competency assessment of Clinical/Medical Laboratory Technicians
  • May coordinate with vendors to initiate the maintenance or repair of instruments
  • Monitors equipment preventative maintenance schedule with Metrology and vendors
  • Monitors reagent and supply inventory and initiates Materials Disposal Form
  • Performs technical review of Laboratory Batch Records
  • Prepares laboratory reagents and assay materials according to Standard Operating Procedures
  • Provides input in development of laboratory documents such as Standard Operating Procedures and laboratory forms
  • Required to follow all safety procedures, Standard Operating Procedures, Equipment Operating Procedures and policies


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 with 4 to 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.

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.

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.

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.

CERTIFICATES, LICENSES, REGISTRATIONS
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.

All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.

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