Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The [Personalis NeXT Platform](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.personalis.com%2Fimmunoid- next-platform%2F&esheet=52534858&newsitemid=20211118006333&lan=en- US&anchor=Personalis+NeXT+Platform&index=2&md5=994af974cf5c973f890d0bc5a72ef63b)® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to Veterans Affairs' Million Veteran Program. To enable cancer and population sequencing, Personalis' [Clinical Laboratory](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.personalis.com%2Fabout%2Flaboratory%2F&esheet=52534858&newsitemid=20211118006333&lan=en- US&anchor=Clinical+Laboratory&index=3&md5=214191f02a8e211e8a6037256ce4a478) was built with a focus on clinical accuracy, quality, big data, scale and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists- accredited.

Personalis is a genome-scale diagnostics company with a mission to pioneer genome guided medicine. Our priority is to obtain the most accurate genetic data from each sample, and then to draw the most reliable medically-focused conclusions from these. Our tests are based on whole human genome and exome sequencing, conducted in our state-of-the art laboratory. We analyze results utilizing proprietary databases, advanced human reference sequences, and sophisticated algorithms.

Located in Menlo Park, CA, Personalis’ genome analysis and interpretation services will help clinical researchers and physicians use genome sequence data to help elucidate underlying disease mechanisms, improve the diagnosis of genetic disorders, guide treatment and drug choice, and anticipate and prevent diseases. We are seeking a talented and highly motivated Quality Assurance Engineer to join our Team.

SUMMARY:

As part of the overall Operations Informatics group, you will help ensure alignment with the processes for software design control, validation, and change management, with a focus on the regulatory and compliance aspects of the lab information systems. The position reports to the Senior Manager, Quality Assurance.

RESPONSIBILITIES:

• Work closely with a variety of internal stakeholders on ongoing development and continuous improvement of the lab information systems quality processes.
• Work with the Quality team in the following areas, in the context of the Operations Informatics systems, to:
  • Generate software deliverables and documentation as per company-established processes and procedures.
  • Participate in software risk analysis activities.
  • Drive software system validations.
  • Support investigations related to the software and product/process issues.
  • Ensure proper documentation of the investigation and corrective actions.
• Work with other members of the Operations Informatics team to:
  • Participate in requirements and design review meetings and create comprehensive test strategies/plans.
  • Design, create, enhance and maintain detailed test cases and conduct hands-on testing.
  • Provide accurate planning, clear strategies, and milestones for testing leading to successful implementation and timely project completion.
  • Coordinate and perform IQ, OQ and PQ and keep proper documentation.
  • Report, track and escalate anomalies discovered during testing and ensure closure on issues.
  • Write and update SOPs for software releases.
  • Perform other duties as assigned.
• Participate in the Quality-Regulatory meetings and other related activities of the Operations Informatics group.
• With guidance from the Quality Assurance & Regulatory Compliance team, participate in the review of software related policies, procedures, protocols, reports, and quality records, as needed.
• Participate to Quality Assurance, Regulatory Compliance, and software-related additional projects, as needed.

REQUIRED EDUCATION/EXPERIENCE:

• M.S. in Bioinformatics, Computer Science, Biology, Physics, or a related field, plus 3 years of Software Quality Assurance experience; or an equivalent combination of education and experience.
• Experience with SOX regulations, as well as IEC 62304, 21 CFR Part 820, ISO 13485, and 21 CFR Part 11 requirements, in a software environment.
• Experience with at least one programming language, with a strong preference for Python and Java.
• Experience working in a Linux/UNIX environment.
• Detail-oriented work style.
• Familiarity with industry software development procedures, in particular Agile development strategies.
• Collaborative approach to identifying problems and implementing solutions.
• Excellent communication skills.

**DESIRED EXPERIENCE: **

• Familiarity with ISO 14971.
• Familiarity with Cyber Security and IT Infrastructure validation.
• Certification in Software Quality Engineering, e.g. the ASQ CSQE certification.
• Experience in a regulated medical, device/diagnostics environment.
• Experience with developing and supporting software in a regulated environment, e.g. CLIA, CAP, etc.
• Experience with high throughput lab information systems in a production environment.
• Experience with business process analysis.

Personalis is an equal opportunity employer. Personalis offers a competitive compensation package. If interested, please submit a letter of interest, resume and salary requirements to careers@personalis.com

_ #LI-RF1_