Sr. Clinical Laboratory Scientist 10/11/2017
Prometheus Laboratories Inc
San Diego, CA
JOB DESCRIPTIONAPPLY DESCRIPTION
Prometheus Laboratories Inc. is committed to improving lives through the development and commercialization of novel pharmaceutical and diagnostic products that enable physicians to provide greater individualized patient care. Prometheus became part of Nestl Health Science in July 2011. Prometheus corporate offices are located in San Diego, California.
Performs pre-analytical and analytical testing, interprets and reports patient results to ordering physicians.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Responsible for quality control, testing and reporting of laboratory test results for all test methods approved by CAP, NY and CLIA
* Organizes patient specimen and assay worksheets for testing and monitors WIP
* Provides direct and constant guidance to Clinical Laboratory Technicians as required by applicable state and federal regulations
* Evaluates performance of assay and quality control parameters, recommends corrective action(s) to laboratory management, and re-evaluate standards/controls
* May act as a designee in the absence of the Team Lead including releasing holds, attending Quality Control/Quality Improvement meetings, acting as a liaison to Client Services, and scheduling shifts
* Maintains schedule for Analytical Measurement Range, Calibration/Verification, and Linearity and ensures that they are performed
* Submits sample request to Corporate Biobank
* Actively provides input for process design and improvement activities
* May participate in cost analysis projects
* Assists with the implementation of new test methods from Research or external sources
* May act as departmental representative for cross-functional projects
* Assists with and may coordinate technical studies designed to improve or validate clinical laboratory testing methods
* Performs testing on clinical study samples as needed
* Monitors equipment preventative maintenance schedule with Metrology and vendors, ensures that OOS sticker is on equipment, and parallel assays are performed on equipment
* Performs qualification on materials and/or instruments used in laboratory operations, ensures material qualification is completed in a timely manner, completes qualification paperwork, and initiates/investigates out of specification and nonconforming material reports
* May perform direct observation for competency assessment (including pipette competency assessment) of Clinical Laboratory Technicians and Clinical Laboratory Scientists
* Monitors reagent and supply inventory and initiates Material Disposal Form
* Reviews preventative maintenance records and service reports
* Performs preventative maintenance and calibrations on laboratory equipment
* Performs technical review of Laboratory Batch Records and closes Manufacturing Orders
* Prepares laboratory reagents and assay materials according to Standard Operating Procedures
* Writes laboratory documents such as Standard Operating Procedures and laboratory forms
* Required to follow all safety procedures, Standard Operating Procedures, Equipment Operating Procedures and policies
* Assists with CAP and NY state inspections and self-inspections
* Receives material transferred from 9449 building
* Provides training to other laboratory personnel
* Other duties as assigned.
EDUCATION and/or EXPERIENCE:
Position generally requires a Bachelors degree, advanced degree preferred and 8+ years related experience. Current California CLS license required. Experience working in a high complexity CLIA/CAP environment preferred. Data entry and Microsoft office skills strongly preferred. Previous experience providing guidance and direction to other laboratory personnel highly preferred. Previous experience managing projects preferred.
Prometheus is an equal opportunity and affirmative action employer and is looking for diversity in qualified candidates for employment: Minority/Female/Disabled/Protected Veteran. If you require an accommodation in order to view or apply to open positions, please email: firstname.lastname@example.org.
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