Technical/General Supervisor, CLIA Laboratory

Employer
Amprion Inc
Location
San Diego, CA
Posted
May 15, 2018
Required Education
Masters Degree/MBA
Position Type
Full time

Amprion Inc is an emerging biotech company developing a novel diagnostic platform for neurodegenerative diseases and is based in San Francisco and San Diego.  We are seeking a Technical Supervisor with experience in establishing CLIA labs and launching new tests to join our growing medical diagnostics team in our San Diego-based lab. Initial responsibilities will include standardization of all laboratory processes and systems to prepare for and obtain CLIA certification, including oversight of method validation and component specification and stability programs, and establishment of equipment calibration and maintenance systems. Longer-term responsibilities to include oversight of day to day operations of a State of California, CLIA-licensed clinical sample testing laboratory.

 

Representative Responsibilities: 

  • Work with Regulatory and Scientific staff to transfer, validate, and launch new testing services.
  • Work with Regulatory and Scientific staff to identify, design and establish processes and SOPs for all associated activities required to achieve and maintain compliance with CLIA, State of California and other applicable regulatory requirements.
  • Supervise day-to-day operations of the laboratory including management of accessioning, test performance, analysis and release of patient results, and proficiency testing.
  • Perform routine laboratory testing using Amprion’s technology platform as well as other analytical technologies, such as HPLC. 
  • Train, manage, and ensure competency of all testing personnel.
  • Work with the Laboratory Director and quality staff to maintain an effective Quality Control program for the clinical laboratory.
  • Ensure compliance with all applicable regulations, including the State of California, CLIA, FDA, HIPAA, and OSHA.

 

Qualifications and Skills 

    • Master’s degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution, or the equivalent.
    • Current State of California license in Medical Technology/Clinical Laboratory Science required. If candidate holds a limited license, it must include a Chemistry sub-specialty. 
    • Minimum of 2 years of laboratory training and/or experience in high complexity testing.
    • Minimum of 2 years of supervisory experience in a CLIA-certified lab preferred.
    • Demonstrated proficiency in patient testing, quality control, quality assurance, project management, and analysis of results.
    • Knowledge of CLIA regulations and CAP guidelines.
    • Knowledge and understanding of laboratory operations; prior experience with LIMS systems, document management systems, plate readers, liquid handling systems, and experience establishing a new laboratory or department that successfully achieved CLIA certification is preferred.
    • Self-starting, highly organized scientist with a problem-solving mindset and capable of operating in an entrepreneurial, fast-changing environment

 

 

Amprion provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Amprion complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

 

Amprion expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Amprion’s employees to perform their job duties may result in discipline up to and including discharge.