CLIA Lab Manager - South Plainfield, NJ

GMG : NGS

Positions
1
Location
GENEWIZ NJ

Do you have experience with Next Generation Sequencing and knowledge of up-and-coming genomics technologies? Want to be part of a company whose goal is to be the best in the world and the best for the world?? 

Our goal is to make clinical diagnostic testing more readily available. We apply cutting edge technologies that provide a wide array of molecular genetic diagnostic tests, including whole exome sequencing and next-generation sequencing panels. This position manages the administration of a department performing a wide variety of testing of clinical DNA specimens using manual and automated methods in a team environment, following established policies and procedures in a professional manner. 

Location:  South Plainfield, NJ 

Responsibilities: 

  1. Design and execution of validation of NGS assays meeting CLIA/CAP standard.
  2. Ensures the day to day supervision and management of high complexity next-generation sequence testing personnel following established standard operating procedures for specimen handling and processing, test analysis, reporting of results to team leads, supervisors and test managers, and record-keeping 
  3. Monitors clinical activities with CLIA laboratory to ensure that acceptable levels of analytic performance are maintained, to include review of quality control, instrument and equipment maintenance, and other quality assurance activities.
  4. Assuring that all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications.
  5. In the event of non-conformances, ensuring that results of test examination are not reported until all corrective actions have been taken and the test system is properly functioning.
  6. Verifying that staff are trained and competent prior to performing testing on patient specimens independently.
  7. Verifying that testing personnel are evaluated initially at six months and thereafter annually, as being competent for assigned tasks and that remedial action is performed when staff do not perform as expected.
  • Organizes and improves laboratory work-flows and processes.
  • Has in-depth knowledge of genomic, high complexity and diagnostic testing.
  • Must be able to demonstrate strong problem-solving skills in troubleshooting technical problems that may affect test performance.
  • Implements standard protocols, practices, procedures and techniques for effective safe operations of the diagnostic laboratory.
  • Follows standard procedures for accuracy and high productivity.
  • Assists in the design and performance of test validations, and test implementation.

 

Qualifications: 

  • Must have strong knowledge of next-generation sequencing, including wet and dry lab, and other molecular pathology methods.
  • Meets CLIA and NJ personnel standards criteria for CLIA Lab Manager of a high-complexity testing laboratory
  • Doctoral degree in clinical laboratory science or chemical, physical or biological science with >1 year of training and experience in high-complexity testing OR
  • Master's degree in clinical laboratory science, medical technology or chemical, physical or biological science and >3 years’ training and experience in high-complexity testing
  • Histopathology experience, preferred
  • Experience with NanoString technology, preferred
  • ASCP certification in Clinical Laboratory Science is preferred.

 

GENEWIZ is a leading global genomics service company and trusted provider for DNA sequencing, gene synthesis, molecular biology, next generation sequencing, bioinformatics, and GLP regulatory services.

GENEWIZ has a strong commitment to both our customers and driving research forwardWe utilize the latest technology (Illumina NovaSeq, PacBio Sequel, 10x Genomics) across a wide-array of research areas (Oncology, Immunology, Metagenomics, Agriculture) to answer almost every biological question.

From the company’s founding, GENEWIZ has maintained its unwavering commitment to providing customers with the best value. Excelling in both science and customer support, GENEWIZ is dedicated to accelerating scientific discovery, as well as to developing and delivering innovative solutions for translational medicine and healthcare. Easily accessible around the world, GENEWIZ is the preferred partner at leading academic, pharmaceutical, biotechnology, agricultural, government, and clinical institutions.

GENEWIZ employees have a winning attitude and champion innovation, teamwork and accountability through a results-oriented, customer-centric, and fun culture. We offer various health and financial benefits, learning opportunities, competitive compensation, rewarding bonus programs, and a wide range of work/life benefits designed to make your life easier.