POSITION DESCRIPTION

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.

SUMMARY:

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.

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:
    • 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.

REQUIRED EDUCATION/EXPERIENCE:

  • 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.

DESIRED EXPERIENCE:

  • 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. 

 

 #LI-RF1

Apply for this Job

* Required

  
  
When autocomplete results are available use up and down arrows to review
+ Add Another Education


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Personalis, Inc are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.