Quality Specialist 2, Lab Operations at Personalis | Powderkeg

The __ Laboratory Operations Quality Specialist will be an integral member of the Clinical Lab Operations team supporting our Next Generation Sequencing services for immune oncology research. The primary responsibilities are to assist in the investigation and management of activities related to Nonconformances as well as Corrective and Preventive Action (NC/CAPA) processes. This involves working closely with the clinical lab team as well as quality in a collaborative environment to resolve quality issues. If you enjoy working in a fast paced, clinical NGS laboratory and have a love of investigating and solving challenges, look no further!

Key Responsibilities:

  • Monitor, trend and analyze operations performance data and client feedback and make a risk-based decision when further action is required
  • Documents and performs timely corrections, performs investigation and isolates a root cause of the issue and communicates regarding issues and resolutions to the NC/CAPA coordinator, Quality team and Ops Lab, etc
  • Performs and/or works with multi-functional teams on to identify a Root Cause root cause(s) of the issue(s) Analysis investigations .for CAPA’s, NCR’s and deviation
  • Plan and define an appropriate corrective and preventive action, evaluate the risk/impact of the action plan on the QMS processes, define timelines of implementation and submit the plan for review and approval
  • Plan, define, assess impact and document Planned Deviations as well as submit for approval
  • Lead weekly NC/CAPA meetings with the Operations laboratory management team, represent Lab Ops in CAPA Board meetings and communicate results amongst stakeholders
  • Work with NC/CAPA coordinator to track and trend CAPA’s, NCR’s and Planned Deviation for timely completion. -1
  • Become the Subject Matter Expert (SME) for all activities related to the CAPA program within Laboratory operations including audit support
  • Communicate complaint information and assist with the Complaint Handling process
  • Additional duties as assigned.

Basic Qualifications:

  • Bachelor’s degree in Life Sciences (i.e. Cellular, Molecular, Biology) with a minimum of 3 years in a Quality role in an NGS CLIA laboratory
  • Experience in quality system methodologies including but not limited to CAPA, Lean, 5 Why’s, Pareto Analysis
  • Ability to compile data and critically summarize results
  • Thrives in a high-energy, hands-on environment
  • Expert level use of Word, Excel, and PowerPoint and experience with electronic documents management systems (EDMS)

About Us:

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 an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package. _


Job Summary
  • Job Title
    Quality Specialist 2, Lab Operations
  • Company
  • Location
    Menlo Park, CA
  • Employment Type
    Full time
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