CLIA Lab, Quality Management Systems (Genetic Testing Lab) – Direct Hire/Will Relo
Our client, an emerging biotech with a CLIA-certified lab in Durham, NC, is actively recruiting for a very sharp, knowledgeable, focused and can-do candidate to drive Quality efforts for its genetic testing lab.
This company is developing genetic testing that will support families with embryo selection. Its technology reports on the genetic make-up of each embryo, helping to assess their viability, enhancing the likelihood of a successful outcome.
This QMS Specialist will drive all Quality efforts and will play a critical role in ensuring that lab operations run cleanly and in compliance with regulations.
Company will pay generous wage to attract and retain the right candidate. Relo support is available.
- Manage Laboratory Quality Management System (QMS)
- Maintain and revise as needed the laboratory Quality Management Plan, Quality Control protocols, and Quality Assurance program
- Perform internal audits of the laboratory, including both technical and quality systems audits
- Perform and document lab process deviations, corrective / preventive actions (CAPA), including follow-up monitoring to gauge the overall effectiveness of such measures
- Monitor monthly lab QC: sign off on new reagent QC, batch records, sample failures, TAT, and other required monthly metrics
- Lead monthly QA Meeting: ensure lab QC metrics are discussed, CAPAs, PDs are reviewed
- Schedule and maintain equipment calibration, IQ/OQ, and system checks
- Manage Lab Licensure (CAP, CLIA, NYSCQ, etc.)
- Ensure laboratory QMS meets all certification requirements
- Work with Laboratory Director to ensure all required validations are completed and meet certification requirements
- Maintain a close working relationship with all regulatory agencies and states to ensure all laboratory certification applications and renewals are completed and approved
- Manage the Laboratory Document Control System (MediaLab)
- Maintain and update the laboratory SOPs, maintenance records and laboratory forms
- Ensure the document control system is operating to efficiently meet the laboratory needs and regulatory requirements
- Implement and Manage Proficiency Testing
- Implement/maintain a proficiency testing program that is compliant with regulatory requirements
- Ensure all proficiency testing is accurately completed and submitted within allotted deadlines
Targeted candidate will offer a related BA/BS degree (advanced degree desirable) and 4+ years in a CLIA-certified lab, including substantial experience with Quality Control and Quality Assurance protocols. Deep knowledge of CLIA, CAP requirements expected and essential.
Other priorities include:
- Experience with genetic testing, including knowledge of Next-Generation Sequencing (Illumina). Preimplantation genetic testing (PGT) would be a plus
- Strong operational savvy
- Experience in a start-up/building setting – significantly contributing to SOP development and implementation
- Outstanding project management/organizational skills
- Knowledge of NY and CA regulatory requirements would be a plus
Finally, we seek a candidate who will thrive in a growing setting; Someone who is versatile, resourceful, adaptable, focused and, when they see a problem, helps to solve it.
This is an outstanding opportunity to join a company that is doing important, impactful work.
Please forward resume for prompt consideration.