QA Specialist - Contract

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.

The QA Specialist is an integral member of the Personalis Quality team. The primary responsibilities are to assist with ongoing support of the established Quality Management System. This individual helps drive compliance in accordance with CLIA, CAP, ISO 15189, ISO 13485, 21 CFR 820 and other regulations and guidance as applicable.  The QA Specialist has knowledge and experience working in CAP accredited / CLIA Certified, ISO 15189 Certified Clinical Laboratories and/or ISO 13485 or 21 CFR 820 regulated environments and sufficient knowledge and experience working in Quality to operate with minimal supervision.  This position reports to the QA Director.

This position is a 6 month temporary position with potential for extension depending on performance and company need. 

• Tuesday - Saturday on site support
• Flexible hours
• 20 - 30 hours per week

Responsibilities:

• Review of Quality Records / Batch Records for compliance with internal procedures and contracts
• Provide guidance and support to staff on Good Documentation Practices
• Inspect and release raw and in-process materials in compliance with internal specifications and procedures
• Represent Quality at the Supplier and Material Quality Review Board 
• Collaborate with Supply Chain and Materials Management to establish material specifications
• Maintain policies and SOPs to ensure the effectiveness of Material Qualification processes
• Help drive continuous improvement initiatives in support of Quality Systems, as applicable
• Execute study specific Quality Audits in support of clinical trial partnerships, as applicable
• Update procedures to reflect changes to QMS including validation of eQM, as applicable
• Ensure documentation and data related to the requirements of the Quality System are controlled.
• Assist in the investigation and root cause analysis teams for CAPAs, deviations and non-conformances.
• Support audits for licensure and accreditation documents submission 
• Additional Quality related duties as assigned

Requirements:

• Bachelor's degree with a minimum of 2+ years in a Quality role
• Ability to compile data and summarize results
• Excellent written and verbal communication skills
• Experience with ISO Standards and FDA-regulated environment highly desirable
• Experience in quality system methodologies
• Strong desire to work in a demanding, high-energy, hands-on environment
• Expert level use of Word, Excel, and Google Suite; experience with electronic quality management systems

The hiring range for this position is $42.00 to $50.00 per hour, which may factor in various geographic regions. This shift is eligible for an additional shift premium.

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.

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