Clinical Laboratory Scientist I (CLS I), Clinical Validations

Ambry Genetics; Aliso Viejo (CA); Hybrid; Full time

Job summary

An innovative healthcare company is seeking a Clinical Laboratory Scientist I to lead validation projects and ensure compliance with industry standards. This role involves collaborating with various teams to validate new assays and improve laboratory processes. The ideal candidate will have a strong background in laboratory science, excellent communication skills, and a keen attention to detail. Join a dynamic team dedicated to advancing genetic testing solutions and making a meaningful impact on healthcare. This is a unique opportunity to grow your career while contributing to groundbreaking advancements in genetics.

Benefits

401k

Medical insurance

Dental insurance

Vision insurance

Paid sick leave

Generous PTO program

Qualifications

• 1+ years of experience in validations and writing validation summaries.
• Bachelor's degree in a relevant science or medical technology.

Responsibilities

• Lead validation projects and collaborate with cross-functional teams.
• Ensure compliance with CAP, CLIA, and NY guidelines.

Skills

Validation of methodologies

Communication skills

Data analysis

Attention to detail

Education

Bachelor's degree in a relevant field

Tools

Laboratory equipment

Office software

Job description

Clinical Laboratory Scientist I (CLS I), Clinical Validations

Job Category: Research & Development

Requisition Number: CLINI004100

Posted: April 8, 2025

Employment Type: Full-Time

Work Model: Hybrid

Location

Headquarters
1 Enterprise
Aliso Viejo, CA 92656, USA

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

Role Overview:

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 cross-functional groups.
• Evaluate new in-house and third-party 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.
• Bachelor's 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 one-to-one, 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.

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 dedicated to open scientific exchange 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 401k, medical, dental, vision, FSA, paid sick leave, and a generous paid time off (PTO) program. Ambry Genetics is an Equal Opportunity Employer (EOE) and we maintain a drug-free work environment.

The Company believes in second chance employment. Qualified 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 Act.

All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex, sexual orientation, gender identity, gender expression, national origin, ancestry, age, marital status, or protected veteran status and will not be discriminated against on the basis of disability, protected medical condition, 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.