South San Francisco, CA

Quality Assurance (QA) Senior Specialist - Clinical

Apply Now

Position description

The Quality Assurance Senior Specialist / Quality Engineer is an enthusiastic, self motivated person with great communication skills who can support the CAP and CLIA compliance aspect of Counsyl's business. Proficiency testing, and learning the inner workings of Counsyl’s quality management systems in our clinical and next generation sequencing clinical laboratory will be a must! The Senior Specialist / Quality Engineer will demonstrate a high level of individual responsibility and accountability and possess the ability to perform the requirements listed below. The candidate will be comfortable in a rapidly evolving Biotech start-up environment, supporting systems for CLIA, CAP, CLEP.

What you'll do:

  • Maintain, support and improve quality systems: Proficiency Testing, Clinical Licensure: National / State, Clinical workflow documentation, Internal Auditing, Gap analysis to clinical standards, driving projects to close gaps, Process trends / metrics / scorecards, CAPA / Occurrence Management.
  • Assist in new system building or major system revamp and update corresponding standard operating procedures as per CLIA, CAP, CLEP utilizing tools such as: JIRA, Veeva Vault, Confluence.
  • Monitor quality metrics as they relate to quality management systems to drive areas of improvement.
  • Manage, review, verify documentation to ensure they are completed in a timely manner and meets Good Documentation Practices
  • Lead continuous improvement project(s).
  • Any and all other undefined tasks, as directed by your supervisor: We are a growing start up, implementing QMS and entering new compliance paradigms, new tasks, duties and projects are normal in such a dynamic environment.

About you:

  • B.S./B.A. in Life Sciences, Chemistry, or Engineering with 5+ years or a Masters an 3+ years in a quality assurance role within a Clinical Diagnostic environment.
  • Exceptional attention to detail and organizational abilities a must.
  • Basic understanding of Chemistry and Molecular Biology, as it pertains to DNA sequencing is a must.
  • Experience in a FDA cGMP or ISO 15189 / 13485 environments is a plus.
  • Knowledge and/or experience with Operations Excellence: Six Sigma, Kaizen, LEAN, 5S, and continuous improvement techniques, etc. a very strong plus.
  • ASQ or other quality related certifications will be viewed favorably.

About Counsyl

Counsyl is a health technology company that offers DNA screening for diseases that can impact men, women and their children. The Counsyl philosophy is simple: screen for diseases where advanced knowledge makes a difference in health outcomes, whether it’s changing a behavior, pursuing preventative measures, or simply preparing for what lies ahead.

The Counsyl team includes an accomplished group of problem-solvers — top engineers, scientists, and designers — who are taking the lead on building the modern clinical laboratory. Scientific rigor, custom robotics, and software are at the heart of every Counsyl product, resulting in better, faster and more affordable screens that are broadly accessible. Beyond the laboratory, Counsyl offers doctors and patients a technology platform for results delivery in real time, with on-demand access to board-certified genetic counselors.

Counsyl has screened more than 750,000 patients and served more than 10,000 health care professionals in its CLIA-certified, CAP-accredited and NYS CLEP-permitted clinical laboratory. The company has raised a total of $102 million and is privately backed by Pilot Growth Equity, Goldman Sachs Asset Management, Founders Fund, Felicis Ventures, David Drummond, and other high profile investors.

Interview process

Counsyl is driven by some of the brightest people in the industry. Our interview process is geared to ensure that we continue to hire the very best. We are an equal opportunity employer and value diversity at our company.

Our interview process is composed of practical and situational interviews in a series of settings spanning Skype, practical exams, and in-person meetings. Our goal is to gauge both your ability to succeed in the first 90 days as well as your capacity to scale with us as we grow.

Why Counsyl?

Throughout it all, we are looking to understand why you are driven to be a part of our company. Specifically, we want to know how you identify with our mission and will contribute to our team.

Apply Now