Quality Associate 2

Personalis • Fremont, CA

1d • $85,000 - $95,000 • Onsite

About The Position

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.

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

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees