Quality Control Technologist III
Employment Type: Full-Time
Labcorp Drug Development is hiring a Quality Control Technologist for our Los Angeles, CA location (1st shift)
Perform duties of Technologist I, or II, and may perform duties of Sr Tech in addition to the following additional duties:
* Demonstrates thorough working knowledge of instruments/equipment in the department.
* Works with the vendor where needed to resolve instrument/ equipment related problems and summarize results of investigations.
* Monitors and initiates instrument and equipment maintenance activities, coordination with management and suppliers.
* Coordinates the timely development and completion of training materials and checklists.
* Seeks and promotes expertise in department and across sites to ensure consistent approach to training.
* Monitors and initiates revisions to SOPs or writes new SOPs to reflect current processes that ensure Coordinates with other departments and other sites to ensure timely completion of SOP. Resolves obstacles, where needed.
Instrument, Equipment, Reagent and Control Validations
* Responsible for coordinating with other resources to ensure timely completion and implementation of installation, operational and process qualifications (IQ/OQ/PQ)
* May be asked to research, develop, validate and maintain procedures in area of responsibility and make recommendations on modification/improvement of procedures to management.
* Maintains oversight over tissue and analyte/kit inventory processes (e.g. Control and validation samples, antibodies, probes and kits), and associated databases.
* Provides support for REES temperature and environmental monitoring.
* Able to analyze existing processes and create new approaches or ideas to Works with internal/external department to ensure successful implementation of changes/improvements.
* Demonstrates extensive knowledge of all department functions, and may serve as subject matter expert for department on company-wide initiatives (e.g. Lean Six Sigma).
Supports client audit process and responding to inquiries.
Tracks and coordinates Proficiency Testing activities in cooperation with supervisory personnel, quality assurance, and the medical director.
Serves as an expert in all facets of trained workstations in area of
Responds to problems or questions of department staff.
Serves as primary response coordinator for Laboratory queries ion Final Study Reports (FSR).
Only individuals that are verified to qualify as supervisory personnel under regulations/standards applicable to the facility (e.g., New York State, CLIA, CAP) may perform periodic review and approval of quality control program records (e.g. quality control data, instrument logs, reagent logs). The SOPs applicable to the department should be consulted to determine records that can be reviewed.
U. S. Requirements
Individual must qualify as testing personnel under the following CLIA 1988 and New York State Department of Health requirements:
* Bachelor's degree in Medical Technology or Clinical Laboratory Science or other life science with completion of at least a 12-month training program in Medical Technology.
* Bachelor's degree in a chemical, physical or biological science from an accredited college or university and one year training and/or experience in the specialty in which testing is to be performed. Such training must be equivalent to that received in a school of Medical Technology.
* 90 semester hours from an accredited institution that include the following:
1) 16 semester hours of biology courses, which are pertinent to the medical sciences
2) 16 semester hours of chemistry (at least 6 semester hours of Inorganic Chemistry)
3) 3 semester hours of math
* Completed an accredited clinical laboratory training program, or one year documented laboratory training or experience in the specialty that testing is to be performed.
* Associate's degree in medical laboratory technology
NOTE: Technologist IIIs who perform supervisory function must qualify as NYS Supervisor under Title 10 NYCRR Part 58-1.3, which includes, but is not limited to the following:
The supervisor is qualified as a medical technologist pursuant to the provisions of section 58-1.5(b) and has had at least six years of pertinent clinical laboratory experience subsequent to qualifying of which at least two years have been spent working in a clinical laboratory having a director at the doctoral level. The clinical laboratory or blood bank shall be part of a hospital, university, health department, medical research institution or other institution which provides equivalent training.
Individual must have 3 or more years of Labcorp Drug Development Laboratory experience performing clinical laboratory testing or experience in performing clinical laboratory testing judged as equivalent.