Compensation: $46/hr. - 50/hr. You are eligible to a Short-Term Incentive Plan with the target at 5% of your annual earnings, terms and conditions apply.
CLS I, Clinical Validations-R&D (Hybrid-Aliso Viejo, CA) - Onsite a minimum of 3 days per week
Job Overview:
The Clinical Laboratory Scientist I (CLS I) is responsible for leading the validation of new assays and process improvements to the clinical laboratory of one to two assigned methodology workflows. This is to be done while following all standard operating procedures of the laboratory and adhering to all quality regulations. Additionally, the technologist may be assigned duties by the Clinical Validations Manager, Clinical Validations Supervisor, and Clinical Validations Lead.
Essential Functions:
- The CLS I, 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.
- Ensure validation plans and reports are written per CAP, CLIA and NY requirements alongside developing and/or updating the SOPs appropriately.
- Coordinate initial training of workflow personnel on any newly developed or updated 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.
- Able to suggest clinical workflow improvements or suggestions in a constructive, collaborative manner.
- Other duties as assigned.
Qualifications:
- Possesses a bachelor's 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 of California.
- Licensed Clinical Genetic Molecular Biologist Scientist Limited CLS license, or license classified as a Generalist CLS. Highly successful and consistent performance in quality and efficiency of work.
- Experience performing validations on one or two methodology workflows including writing up the validation summary adhering to CAP, CLIA and NY guidelines. Analysts in their training phase are allowed to perform technical validations, but their work requires senior analyst review.
- Technical knowledge of laboratory testing and terminology.
- Capable of excelling within a team environment.
- Capable of accomplishing workload and additional projects daily.
- 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, validation summaries, and correspondence.
- Ability to speak effectively one-to-one, in group settings, with clients, vendors, and employees of the organization.
- 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.
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 with a 4% employer match, FSA, paid sick leave and generous paid time off (PTO) program. Ambry Genetics is an Equal Opportunity Employer (EOE) and we maintain a drug-free work environment.
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