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 QA Compliance Engineer to join our Team.
You will be a key member of our OPS team of biologists, bioinformaticians, and automation engineers working to develop a highly automated lab and achieve a substantially shorter sample turnaround time. This position will support the implementation of 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, QA & Compliance.
- 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:
- Assure and ascertain compliance with SOX regulations, as well as IEC 62304, 21 CFR Part 820, ISO 13485, and 21 CFR Part 11 requirements.
- Facilitate and/or prepare effective and well documented software risk assessments based on ISO 14971.
- 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.
- Provide QA 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.
- 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.
- Extensive experience with SOX compliance 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.
- Working knowledge of the IEC 62304 standard.
- 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/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package.