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.

Selected Duties:

• 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.