TGen, the Translational Genomics Research Institute, is part of City of Hope. We are an Arizona-based, nonprofit medical research institute dedicated to conducting groundbreaking research with life-changing results. No matter the role, every TGen employee contributes to success. Together, we work toward a common goal: improving medicine to enhance a patient's quality of life. It's not all biomarkers and sequencing; it is a mix of humanity improving the human condition. Find your role at TGen, in an environment ignited by a profound purpose.

We are currently looking for an Associate Director, Clinical Laboratory Quality Assurance to lead and develop Quality Management systems for our CAP/CLIA laboratory. Testing in our clinical lab offers hope to patients through our rapid whole genome sequencing assays that can lead to more precise and individual treatments. Join the team in developing new cutting-edge molecular oncology testing as we expand our offerings.

Job Description

As a member of the CLIA lab, the Associate Director will work closely with the Laboratory Director on the development and monitoring of quality improvement initiatives, quality metrics, corrective and preventative action, and document management system, to include the following.

• Analyze data, identify trends, monitor prevention and correction of quality deviations, and develop reports for management utilizing technical knowledge and laboratory experience

• Ensure continuous compliance with requirements of licensing, accrediting, and regulatory agencies. Reviews regulations and industry trends to ensure Company procedures are current and compliant

• Conduct periodic internal audits for process control and improvement as well as staff competency.

• Document audit observations, evaluate impact, and make recommendations for corrective actions. Evaluate responses to audit findings and ensures that appropriate corrective actions are completed.

• Responsible for document management systems.

• Write and revise SOPs and documents as needed.

• Prepare and deliver training on compliance and quality management tools to management and staff as needed. Assist Operations with the development of additional Quality Assurance and Improvement initiatives as needed.

• Work closely with TGen Compliance to ensure an effective HIPAA program is in place for the laboratory

Perks

We are a human-centric organization that translates to our employees. Some of the perks in working for us:

• BC/BS of Arizona health coverage.

• Dental, Vision, Life, Short and Long Term Disability

• Top notch EAP with a full scope of concierge type services

• 401k with 6% match

• Generous time off

• Commuter benefits

• Much, much more!

Requirements

• BS/BA degree in laboratory science or related field;

• National certification (ASCP, CQA or equivalent) is required;

• Demonstrated knowledge of HIPAA, CLIA, CAP, NYSDOH, GCP and Quality Management Systems (QMS).

• Experience in conducting hosting external audits by regulatory agencies and commercial clients;

• 10+ year experience working in a clinical laborary with a minimum of 5 years' experience in clinical laboratory Quality Assurance and Compliance;

Experience supporting next generation sequencing molecular laboratories

What is ideal?

Knowledge of next generation sequencing, precision oncology, and hematological disorders is preferred