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Laboratory Technical Supervisor

Theranos, Inc.

Location:
Newark , CA
Posted Date:
6/27/2014
Position Type:
Full time
Job Code:
lts062714
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Development, Laboratory, Medical Device, Quality, Research,

Job Description

• Develop a nationally recognized CLIA reference laboratory.
• Ensure compliance with state and federal regulatory agencies, including timely submission of proficiency testing.
• Conduct inspection preparation and lead onsite inspections.
• Act as a Quality Systems Manager and evaluate the policies, procedures, and processes as well as implement laboratory improvements.
• Oversee laboratory Quality Assurance/Quality Compliance and conduct annual review.
• Participate in review/approval of all relevant documents and procedures.
• Ensure smooth operations of high complexity laboratory, including inventory control, results accessioning and reporting, and documentation of variances.
• Achieve greatest level of test accuracy, timeliness and medical value for a growing patient base.
• Documentation and implementation of remedial action whenever laboratory testing deviates from best practices.
• Work with R&D to validate novel testing systems.
• Develop new tests and maintain existing procedures, following NCCLS guidelines for SOPs.
• Maintain patient and laboratory records consistent with state and federal regulations.
• Oversee customer satisfaction and implement procedures for resolving complaints.
• Evaluate, document, and ensure competency of all testing personnel consistent with state and federal guidelines, and high levels of team productivity and collegiality.
• Develop laboratory budget to ensure efficient use of resources.
• Understand and implement OSHA and CLIA requirements.

Requirements

• This role will be located in Palo Alto, CA until Fall 2014 then moving to Newark, CA.
• Bachelor's degree in chemical, physical or biological science or medical technology from an accredited institution.
• Graduation from an accredited CLS program.
• Hold a current Clinical Laboratory Scientist license issued by the State of California.
• At least 4 years of experience in high complexity testing with a proven track record of exceeding quality expectations.
• Excellent analytical and laboratory skills.
• Experience with a broad array of assays including clinical chemistry, hematology, microbiology, and molecular diagnostics.
• Experience managing clinical laboratory personnel.
• Experience managing new laboratories, or sections of laboratories, consistent with best practices and lean/six-sigma principles is highly desirable.
• Experience with preparing for and coordinating laboratory inspections by State and Federal agencies.
• Desire to be part of a fast-paced, rapidly growing start-up company.
• Proficiency with procedures to ensure analytic performance such as Westgard rules and Levey-Jennings analysis.
• Proven ability to help scale clinical laboratories in a dynamic environment while maintaining excellence in performance at every level.

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