Clinical Laboratory Scientist II

Description

JOB TITLE: CLS II, Clinical Validations

DEPARTMENT:  Research and Development-Clinical Validations

REPORTS TO TITLE: Associate Director Clinical Validations

JOB OVERVIEW:

The Clinical Laboratory Scientist II (CLS II) is responsible for following all standard operating procedures of the laboratory and adhering to all quality regulations while leading the validation of new assays and process improvements to the clinical laboratory of one to two assigned methodology workflows. The CLS II will be cross trained on additional methodology workflows to provide further support and team coverage.

DUTIES AND RESPONSIBILITIES:

• The CLS II, Clinical Validations may be assigned to a specific methodology workflow or no more than two workflows.
• Validate an existing or newly developed assay or technology per CAP, CLIA and New York (NY) guidelines.
• Evaluate new in-house and third party software systems and validate the software.
• Ensure validation plans and summaries are written per CAP, CLIA and NY requirements alongside developing and /or updating the SOPs appropriately. The CLS II is expected to be able to work more independently on these documents, and take a primary role in writing them
• Coordinates initial training of workflow personnel and technical trainer on any existing or newly developed assay or workflow.
• Adhere to all Quality regulations (CAP, CLIA & NY State) and ensure all training and competency forms are complete (as necessary).
• Prior to work, ensure that all equipment and instruments work properly, are maintained through preventative maintenance and that instruments have been calibrated or verified for calibration. Ensure work area is safe and clean prior to work and after work.

JOB SPECIFICATIONS

EDUCATION AND KNOWLEDGE:

• Possesses a bachelors degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution or higher.
•  Must possess a current CGMBS or CLS license issued by the State in which the laboratory is located, if such licensing is required.
• Responsible in maintaining any required certificates, licenses, and/or registrations that are required for the position.

TECHNICAL COMPETENCIES

General Skills

• Technical knowledge of laboratory testing and terminology is desirable.
• Capable of excelling within a team environment.
• Capable of accomplishing workload and additional projects daily.

Language Skills

 Ability to communicate effectively, attention to detail, ability to cross reference information, ability to prioritize work, telephone skills, computer skills, working knowledge of standard office equipment (computers, printers fax machines, phone systems, office software and internet).

•  Flexibility regarding job assignments.
• Ability to read and interpret documents and Ambry requisitions, operating and maintenance instructions, and procedure manuals.
• Ability to write validation plans and validation summary and correspondence.
• Ability to speak effectively one-to-one, in group settings, with clients, vendors and employees of the organization.

Mathematical Skills

• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability

• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
•  Ability to deal with problems involving several concrete variables in standardized situations.

EXPERIENCE:

• Bachelor’s degree in chemical, physical, biological or clinical laboratory science or medical technology.
• 2-4 years of experience performing validations on one or two methodology workflows including writing up the validation summary adhering to CAP, CLIA and NY guidelines. CLS II can perform clinical validations independently and possibly able to review CLS I or Research Assistant work.  

About Us

Ambry Genetics Corporation is a CAP-accredited and CLIA-licensed molecular genetics laboratory based in Aliso Viejo, California. We are a genetics-based healthcare company that is dedicated to open scientific exchange so we can work together to understand and treat all human disease faster.

At Ambry, everyone is welcome. A career at Ambry Genetics is a chance to be part of a dynamic company that aims to improve health by understanding the relationships between genetics and human disease. We earned our reputation as industry leaders by responsibly introducing cutting-edge genetic testing solutions and continually sharing what we learn with the global scientific community.

At Ambry you will be learning, challenging yourself, and having fun while collaborating with teammates through the open exchange of ideas. Our outstanding benefits program includes medical, dental, vision, 401k, FSA, and generous paid time off (PTO) program. Ambry Genetics is an Equal Opportunity Employer (EOE) and we maintain a drug-free work environment.

Ambry Genetics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race (and traits historically associated with race, including, but not limited to hair texture and protective hairstyles such as braids, locks, and twists), color, creed, religion, sex, sexual orientation, gender identity, gender expression (including transgender status), national origin, ancestry, age, marital status or protected veteran status and will not be discriminated against on the basis of disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Ambry does not accept unsolicited resumes from individual recruiters, third party recruiting agencies, outside recruiters or firms without an executed contract in place. We are not responsible for any fees related to resumes that are unsolicited or are received by Ambry. Such resumes will be deemed the sole property of Ambry and will be processed accordingly.