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Illumina’s Laboratory Services Group is currently recruiting an experienced Laboratory Director who will be responsible for oversight of our high complexity genetic testing CLIA certified laboratories from either our San Diego or Redwood City locations. Responsibilities include ensuring competency of personnel performing test procedures; recording and reporting test results promptly, accurately and proficiently; and assuring compliance with all applicable regulations. This role will oversee both our Northern and Southern California labs and the other Lab Directors associated with these labs.
Illumina’s CAP/CLIA labs serve a variety of patients using NGS and Array Genotyping as core technologies. The test menu includes Non-invasive Prenatal Testing and Whole Genome Sequencing for Rare and Undiagnosed Disease. This is a highly technical environment in high-complexity testing. We are looking for a leader with technical expertise in molecular biology, experience in running clinical laboratories, and experience managing staff. The primary focus of the lab is execution of existing tests, but we work with R&D on test pipeline and the lab director should be conversant in design control and able to navigate the controlled transfer of design into routine lab practice.
- Provide direction and coordination of the technical and administrative functions for the CLIA Laboratory
- Develop, implement, and maintain a Quality Management System (QMS) for all phases of testing, to include the pre-analytic, analytic, and post-analytic phases of testing as well as general laboratory systems
- Ensure test systems have established acceptable performance specifications for the characteristics of accuracy, precision, analytical sensitivity, and analytical specificity
- Oversee selection maintenance and calibration of instrumentation and equipment used to perform testing
- Establish policies and procedures are established to monitor, assess, and identify problems with analytical test methods, and when indicated that remedial and corrective actions are taken and documented
- Ensure an approved procedure manual is available to all personnel responsible for any aspect of the testing process
- Ensure on-site supervision of high complexity test performance by testing personnel and that qualified personnel perform delegated responsibilities
- Establish policies and procedures for hiring and monitoring individuals who conduct pre-analytic, analytic, and post-analytic phases of testing to assure they have the appropriate education and experience, are competent and maintain their competency to perform the testing procedures
- Confirm the physical plant and laboratory environmental conditions are appropriate for the testing performed and provide a safe environment that protects employees from physical, chemical, and biological hazards and in compliance with all federal, state and local agencies
- Certify the laboratory has established an approved Proficiency Testing (PT) program to include an approved corrective action plan when any PT results are determined to be unacceptable
- Make sure that test reports provide pertinent information required for interpretation and consultation is available to laboratory clients concerning reported test results
Required Certificates, Licenses, Registrations, Skills & Experience
- The laboratory director must be currently licensed as a Laboratory Director by the State of California (BPC 1209) and meet the qualifications for Laboratory Director as specified by CLIA regulations for high complexity testing (42CFR, part 493)
- New York State Certificate of Qualification in Molecular Genetics, preferred
- 5 years’ experience in and oversight of CLIA / CAP Accredited Clinical Laboratories
- Extensive knowledge of molecular biology and medical genetics preferred
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at 858-246-8959. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf