Over the last few years, Counsyl has grown from a dorm room startup to become one of the largest clinical genome centers in the world, processing over 500,000 samples to date. We currently seek to hire a QA Manager to help us create Quality Management SOPs and manage the Quality program for our highly-automated laboratory. You will collaborate with teams across the organization to ensure our lab continues to process our patient samples with the upmost quality and integrity.
What you'll do
- Optimize robust Quality Management System tailored to Counsyl’s fast-paced engineering environment
- Refine processes and QA strategies to ensure compliance with CLIA and FDA regulations
- Define QAIs, present quality metrics, and utilize data to drive quality improvement projects
- Work with different departments to define quality indicators and implement monitoring strategies
- Participate in Quality Systems audits
- Oversee occurrence management system, non-conformance event tracking, root-cause analyses, and follow-up corrective and preventive actions.
- Implement document control structure and organization as well as electronic records management in the most efficient manner possible