Senior Quality Assurance Specialist

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California.

Summary:

The Senior Quality Assurance Specialist will be an integral member of the Quality Assurance team and part of the Personalis Quality, Regulatory and Clinical Compliance organization.  The primary responsibility is to lead the Supplier Management and the Internal Audit processes. The ideal candidate has sufficient knowledge and hands on experience of working in regulated environments (i.e. ISO 13485, 21 CFR 820, CLIA, CAP, NYS CLEP) to operate with minimal or no supervision. This position reports to the Director of Quality Assurance.

Hybrid: Monday, Tuesday and an additional floating day onsite in Fremont

Responsibilities:

• Manages the Supplier Quality program including qualification of new suppliers, regular monitoring and assessment of supplier performance, evaluation of supplier notifications of change and SCARs.
• Performs supplier monitoring based on real monitoring data (Supplier Audit results, CAPAs, NCRs, Supplier Corrective Actions, Significant changes of supplier QMS processes and/or facilities, Changes to the scope of supplier responsibilities and similar) and report results to management
• Develops and maintains all requirements of supplier qualification including audit questionnaires, ISO certifications and other applicable certifications and accreditations;
• Maintains the controlled Approved Supplier List (ASL) and supplier audit / re-evaluation schedule
• Supports implementation of Supplier Quality Agreements and, monitor supplier performance for adherence to these agreements
• Develops, reviews, assesses, coordinates, and maintains all requirements of supplier qualification including audit questionnaires, ISO certifications and other applicable certifications and accreditations.
• Defines and ensures the approval of the Supplier Audit Annual Plan/Schedule.
• Ensures supplier maintenance and periodic monitoring cycles adhere to approved supplier audit Plan/Schedule.
• Leads and supports supplier audits. Completes Audit Reports. Opens SCARs for any supplier audit findings. Follow up on the audit findings until completion/closure.
• Develops, tracks and trends supplier metrics for monthly Quality meetings and management reviews, including a summary of supplier performance effectiveness, and proposes improvements.
• Ensures execution of the supplier-initiated change notification process is timely for processing of change impact. Coordinates with Supply chain, quality compliance, and regulatory to assess and address any risk to the safety of patient and user and performance of supplied parts/service.
• Provides training to the organization across different teams to ensure consistency and compliance to the Supplier Quality processes and procedures.
• Management of the Internal Audit program to assess compliance of the Personalis QMS with ISO, FDA, CLIA and other applicable regulatory requirements; 
• Plans and conducts internal audits as Lead Internal Auditor including recording and reporting audit results to management; performs follow-up activities including tracking and verification of associated corrective actions
• Works with a QA Director in preparing and releasing the annual internal audit plan.
• Analyzes and communicates audit data at the Monthly QA meetings and Management Review.
• Documents findings, identify owners and follow up on corrective actions/corrective actions until closure.
• Supports lab compliance teams in preparing and executing client audits and other activities as required.
• Performs periodic review of Supplier Management and Internal Audit procedures for compliance with regulatory requirements and company standards of practice. 
• Performs CQ audit activities to document findings, identify owners and follow up on corrective actions/corrective actions until closure.
• Supports the execution of designated QMS processes by ensuring that required activities are carried out on time and in accordance with company procedures and policies, and applicable regulatory requirements.
• Consistently demonstrates foundational knowledge of key principles and concepts and some intermediate level knowledge within the QA area. 
• Applies knowledge, critical thinking, company policies and procedures to resolve routine problems independently or with minimal supervision.
• Owns or supports quality daily activities, either independently or with minimal supervision.
• Works as a supporting role on an individual complex task(s).
• Helps drive continuous improvement initiatives in support of all QMS processes.
• Additional duties as assigned.

Complexity & Problem Solving:

• Demonstrated success in compliance proficiency, scientific creativity, collaboration with others and independent thought & problem solving.
• Able to work independently in collaboration with a more senior team member.  
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for solutions.  
• May receive the guidance of a more senior team member within or outside of designated processes.

Requirements:

• Bachelor’s degree in a scientific or technical discipline, or a related field, is required.
• Minimum of 5 years of relevant work experience in QA; experience working on a regulated Medical Device, IVD or Pharma environment is a plus. 
• QA auditing experience or Auditor training qualification (e.g. ISO 13485 Auditor), required.
• Experience in regulated testing environments such as those aligned with ISO Standards ISO 13485; 15189; 14971, and regulated by FDA, highly desirable.
• Familiarity with CLIA, CAP and NYS CLEP regulatory requirements for clinical laboratories
• Excellent organizational skills; results and decision driven.
• Capable of operating in an environment that entails the usage of multiple software tools.
• Must have strong interpersonal and written communication skills.

The hiring range for this position is $105,000 to $130,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Personalis is an equal opportunity employer and is committed to the full inclusion of all individuals. As part of this commitment, Personalis will ensure that persons with disabilities are provided with reasonable accommodations. If you need an accommodation to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please let your recruiter know, if/when they contacts you.

Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package and benefits including medical, dental, vision, 401(k) match, ESPP, tuition reimbursement, sick/vacation time, commuter benefits/ EV charging stations, onsite gym, and wellness benefits. (For US only, benefits in other countries may vary.) 

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