Quality Associate 2

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.

Days Onsite: Tuesday - Saturday from 9:30am - 6pm

Summary:

The QA Specialist is an integral member of the Quality team. The primary responsibilities are to assist in the implementation and management of the Quality Management System. This individual helps drive the Quality Management System implementation in accordance with CLIA, CAP, ISO 15189, ISO 13485, 21 CFR 820 and other regulations and guidance as applicable.  The Sr. QA Specialist has knowledge and experience working in ISO 15189 and/or ISO 13485 or 21 CFR 820 regulated environments and sufficient knowledge and experience working in Quality to operate with minimal supervision. This role will be required to work an offset schedule (e.g. Tueday through - Saturday) to ensure support for the Reagent Manufacturing and Clinical Laboratory Operations over the weekend.This position reports to the Director of Quality Assurance.

Responsibilities:

• Timely performance of Quality review and audits of Clinical Study data in compliance with GCP / GCLP to ensure the accuracy, consistency, and traceability
• Performance of incoming inspection and release of raw and in house materials to assure operations continuity over weekends
• Review of laboratory production records including batch history record, equipment records, and environmental monitoring records, etc
• Preparation of data audit reports for provision to study sponsor
• Verification that laboratory activities and clinical processes adhere to Good Clinical Laboratory Practice (GCLP) and Good Clinical Practice (GCP) guidelines
• Evaluation of  internal Standard Operating Procedures (SOPs) to identify gaps in the workflow that could compromise data integrity.
• Partner with the study project manager to ensure execution of study specific requirementsInitiate and investigate nonconformances / deviations from procedure or specification
• Maintain policies and SOPs to implement effective processes for Quality Audits and oversight of clinical studies
• Help drive continuous improvement initiatives in support of all Quality Systems 
• Actively engage with process owners to resolve documentation errors and nonconformances
• Assist in the investigation and root cause analysis teams for CAPAs, deviations and non-conformances.
• Additional duties as assigned

Requirements:

• Bachelor's degree with a minimum of 3-5 years in a Quality role within the medical device or biotech industry.
• Strong working knowledge of ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate)
• Demonstrated experience auditing laboratory data under GCLP and clinical data under GCP
• Ability to compile data and summarize results
• Excellent written and verbal communication skills
• Experience in authorship of standard operating procedures
• Experience with ISO Standards and FDA-regulated environment highly desirable
• Experience in quality system methodologies including but not limited to CAPA, Lean, 5 Why's, Pareto Analysis
• Must have proven interpersonal, and communication skills
• Strong desire to work in a demanding, high-energy, hands-on environment
• Expert level use of Word, Excel, and Google Suite / Apps and experience with electronic document management systems

The hiring range for this position is $85,000 to $95,000 per year, which may factor in various geographic regions. This position is also eligible for overtime pay. 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.

Protecting Our Candidates: At Personalis, we value your security. Please note that all official correspondence from our team will come exclusively from @personalis.com email addresses. We will never ask for personal financial information or conduct interviews over text or chat platforms. If you receive a suspicious request, it is likely a scam. We are committed to a safe recruitment experience and actively work with authorities to investigate and prosecute cyber crimes targeting our community.

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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