Senior Clinical Laboratory Scientist II - Quality Control

Genomic Health, Inc. Redwood City, CA
Overview:

The Senior Clinical Laboratory Scientist II - Quality Control, is an integral member of the Reagent Manufacturing and Quality team, with the primary responsibility of ensuring the consistent quality of reagents and consumables used by Genomic Health's Clinical Laboratory. He or she is responsible for performing high complexity laboratory testing and contributing to the creation and implementation of required test methods, stability data, associated study protocols, reports and standard operating procedures to ensure quality issues with reagent or consumable lots are discovered and addressed prior to their use in our Clinical Laboratory. The Senior CLS II - QC is involved in preparing and qualifying controls for instruments qualification and assay performance monitoring. He or she will also participate in the investigation of reagent quality issues, help drive continual improvement in efficiency of clinical laboratory and QC workflows, develop new and improve existing QC methods, and train manufacturing or laboratory staff in new processes.

The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multi-task and be flexible with tasks and schedules, and the ability to work both independently and in a team environment.

RESPONSIBILITIES / DUTIES:

* Perform, review, and document reagent quality testing according to the laboratory's standard operating procedures.

* Write, review, and revise reagent Quality testing SOPs and/or related training documents.

* Train laboratory staff in existing and/or new processes when needed.

* Perform competency assessment evaluation according to GHI Clinical Laboratory Training and

Competency Assessment Program.

* Identify and help troubleshoot high complexity issues that adversely affect reagent quality test results.

* Manufacture and qualify process and instrument controls used by the Clinical Lab.

* Participate in cross-functional teams to test and validate new reagents and consumables and conduct

stability studies of reagents.

* Participate in the effort to develop, validate, and implement quality control test methods for reagents

and plastic consumables to reduce the variability of genomic assays used for commercial patient sample

testing and in clinical development studies.

* Ensure consistent compliance with applicable federal, state, and local regulations and quality-related

best practices in development, validation, use, and documentation of analytical and functional test

methods for reagent lot qualification, stability studies, and related activities.

* Assist in investigation and resolution of reagent / consumable-related issues with our laboratory

processes.

* Collaborate with colleagues in Quality, Supply Chain Management, Biostatistics, Process Engineering,

R&D, and other functions to address and prevent supplier quality issues.

QUALIFICATIONS:

* Must possess a valid California CLS license or equivalent, such as CGMBS.

* Clinical laboratory work experience within the last five years.

* Minimum of 10 years of clinical laboratory experience as a CLS, CGMBS or equivalent, with at least 5

years in a high complexity molecular laboratory.

* Possess intermediate to advanced working knowledge of local, state and federal laboratory regulations.

* Hands-on experience with automated equipment, such as Tecan and Hamilton robotic systems.

* Strong computer skills, including but not limited to Microsoft Office and LIMS.

* Strong molecular biology technical skills such as nucleic acid isolation, RNA/DNA quantification, PCR and

RT-PCR, and DNA sequencing.

* Ability to proactively communicate consistently, clearly and honestly and to maintain open

communication with internal employees, managers, and customers as needed.

* Ability to effectively communicate technical information to technical and non-technical audiences.

* Able to manage daily test processing needs along with project needs in a high quality, efficient and

effective manner.

* Ability to work as part of a team.

* Ability to perform repetitive tasks with sustained high quality.

* Willingness to be flexible and adapt to changing priorities.

* Experience with supporting the development of Invitro Diagnostic Products under ISO13485

requirements desirable.