Clinical Laboratory Scientist I CLS I Clinical Validations

Compensation: $40.00 $48.00 per hour. You are eligible for a ShortTerm Incentive Plan with the target at 5 of your annual earnings; terms and conditions apply.

Clinical Laboratory Scientist I (CLS I) Clinical Validations Hybrid

The Clinical Laboratory Scientist I (CLS I) Clinical Validations will be part of the team responsible for validation of new assays and process improvements to be transferred to the clinical laboratory. They will work closely with personnel from Assay Development Automation and Clinical Lab in all aspects of planning and reporting new and updated assays. They will follow all standard operating procedures of the laboratory and adhere to all quality regulations. Additionally the technologist may be assigned validation related duties by their manager.

Essential Functions

• Be the primary project lead on the validation of specific methodology and/or workflow as assigned. Be the team representative on associated project core teams
• Under the guidance of management validate an existing or newly developed assay or technology per CAP CLIA and New York (NY) guidelines
• Collaborate on the design of validation studies incorporating appropriate stakeholder input
• Work with the technical writers as a subject matter expert on the project and ensure validation documents are written per CAP CLIA and NY requirements
• Work with appropriate teams to contribute to developing and/or updating the SOPs
• Analyze and compile data for presentations and documentation. Present to small and large crossfunctional groups
• Evaluate new inhouse and thirdparty software systems and validate the software
• Coordinates and conducts initial training of workflow personnel 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 any lab work ensure that work area is safe and clean all equipment and instruments work properly are maintained through preventative maintenance and that instruments have been calibrated or verified for calibration
• Other duties as assigned

Qualifications

• 1 years of experience performing validations on one of two methodology workflows including writing up the validation summary adhering to CAP CLIA and NY guidelines
• Bachelors degree in a chemical physical biological or clinical laboratory science or medical technology or equivalent work experience
• Licensed Clinical Genetic Molecular Biologist Scientist Limited CLS license or license classified as a Generalist CLS
• Ability to speak effectively onetoone in group settings with clients vendors and employees of the organization
• Ability to write validation plans validation summaries and correspondence
• Ability to apply common sense understanding to carry out instructions furnished in written oral or diagram form

Preferred

• Attention to detail ability to cross reference information ability to prioritize work computer skills working knowledge of standard office equipment (computers printers office software and internet)
• Experience writing validation plans validation summaries and correspondence
• Flexibility regarding job assignments

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About Us:

Ambry Genetics Corporation is a CAPaccredited and CLIAlicensed molecular genetics laboratory based in Aliso Viejo California. We are a geneticsbased 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 cuttingedge 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 outstanding benefits program includes 401k medical dental vision FSA paid sick leave and generous paid time off (PTO) program. Ambry Genetics is an Equal Opportunity Employer (EOE) and we maintain a drugfree work environment.

The Company believes in second chance applicants with arrest or conviction history will be considered regardless of their arrest or conviction history consistent with local laws such as Los Angeles County Fair Chance Ordinance and the California Fair Chance do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check if the Company is concerned about conviction that is directly related to the job you will be given the chance to explain the circumstances surrounding the conviction provide mitigating evidence or challenge the accuracy of the background report. For the purpose of the above job description Essential Functions are Material Job Duties.

Our salary ranges are determined by role level and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range individual pay is determined by work location and additional factors including jobrelated skills experience and relevant education or training.

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. If you have a disability or special need that requires accommodation please contact us at

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.

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