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South San Francisco, CA

Quality Assurance Senior Specialist/ Quality Engineer

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Position description

The Quality Assurance Senior Specialist / Quality Engineer is an enthusiastic, self motivated person with great communication skills who can support the inner workings of Counsyl’s quality management systems in a clinical and next generation sequencing laboratory. 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 based on CLIA, CAP, CLEP, ISO 13485:2016, and FDA QSR regulations.

What you'll do:

  • Support and improve quality systems:
  • Document control
  • Non-conformance resolution / Occurrence Management
  • Equipment qualification and maintenance
  • Personnel trainingInternal/external auditing
  • Manufacturing batch records
  • Management reviews
  • Product Lifecycle Management
  • Supplier Quality Management
  • Technology Transfer / Change / Risk Management.

  • Assist in new system building or major system revamp and update corresponding standard operating procedures as per CLIA, CAP, CLEP, ISO13485:2016, FDA 21 CFR 820 requirement needs 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.

About you:

  • B.S./B.A. in Life Sciences, Chemistry, or Engineering with 4+ years in a quality assurance role or equivalent.
  • Exceptional attention to detail and organizational abilities a must.
  • Experience in a CLIA, CAP, CLEP, ISO 15189 environment is a plus.
  • Basic understanding of Chemistry and Molecular Biology, as it pertains to DNA sequencing is ideal.
  • Knowledge and/or experience with Operations Excellence: Six Sigma, Kaizen, LEAN, 5S, and continuous improvement techniques, etc. a very strong plus.
  • Adept with Mac laptops and Google tools: Gmail, Docs, Sheets, Slides, Drive.
  • 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

Counsyl has renamed its products effective July 19, 2017. The Family Prep Screen is now the Foresight Carrier Screen. The Informed Pregnancy Screen is now the Prelude Prenatal Screen. The Inherited Cancer Screen is now the Reliant Cancer Screen.

The new names now appear on all communications from Counsyl. If you have any questions, please contact Counsyl directly.

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