Quality Assurance Analyst - CLIA Laboratory

SUMMARY

Responsible for the implementation of laboratory quality assurance procedures in the clinical laboratory to ensure compliance with all regulatory, environmental and health and safety parameters.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: Other duties as assigned.

• Assist in the implementation and maintenance of the diagnostic laboratory quality processes.
• Works closely with the LIMS Configuration Manager to define and manage test, equipment and reagent definition in the Laboratory Information System
• Identifies opportunities to continuously improve quality, cost and time factors and workflow issues within the laboratory.
• Collect and analyze quality data daily/weekly/monthly for any shifts or trends. Evaluate indicators, prepare and post monthly reports
• Work closely with Purchasing Manager and Finance for accurate Cost of Goods of diagnostic products
• Work closely with Lab Manager in scheduling performance of assay linearity and analytical method reportable range per regulatory requirements.
• Works closely with Lab Manager to ensure that assays, instruments, and reagent parallel testing is conducted for appropriate documentation and qualification.
• Works closely with Metrology to review calibrations, equipment qualifications and preventative maintenance records. Updates Blue Mountain RAM database accordingly.
• Manages both internal and external proficiency testing programs.
• Administers annual proficiency/competency assessments in accordance with regulatory requirements
• May participate in process design and continuous improvement activities such as: quality, safety, document management, proficiency testing and collaborating cross functionally.
• May write and revise laboratory documents such as standard operating procedures and departmental forms.

SUPERVISORY RESPONSIBILITIES

No direct supervision.

QUALIFICATIONS
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 Bachelor's Degree in Biologic Sciences. California Clinical Laboratory Scientist License required and American Society for Clinical Pathology, MT (ASCP) certification preferred.

Minimum of 8 years of recent experience in a relevant industry (biotech, clinical or research laboratory) required. Experience working in a high complexity CLIA/CAP environment preferred.

Data entry and Microsoft office skills strongly preferred.

LANGUAGE SKILLS
Ability to read and interpret documents such as, vendor specifications, safety rules, 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 read and analyze financial data.

REASONING ABILITY
Ability to define problems, collect data, establish facts and draw reasonable conclusions. Ability to understand and comply with all applicable laboratory regulated guidelines.

CERTIFICATES, LICENSES, REGISTRATIONS
California Clinical Laboratory Scientist License required. American Society for Clinical Pathology, MT (ASCP) certification preferred.

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 and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance 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 in a CLIA laboratory 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 moving mechanical parts, fumes or airborne particles, potentially infectious bodily fluids, toxic or caustic chemicals, and extreme cold. The noise level in the work environment is moderate.

The statements herein are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

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.