Grailbio3mo ago

Lead Quality Audit Specialist # 4572

United States·DurhamFull-Timelead

Finance & AccountingOtherAudit Specialist

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Overview

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

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Finance & AccountingOtherAudit Specialist

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

For more information, please visit grail.com

The Lead Quality Audit Specialist is responsible for supporting the development, implementation and maintenance of the internal audit program. This role will also support other Quality Management Systems (QMS) activities as needed.

This role is based at our Durham, North Carolina, office. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site.

Responsible for creating annual internal audit schedules, developing internal audit plans and coordinating activities with cross-functional teams.

Function as a lead auditor for internal audits and perform audits to ensure compliance to procedures and regulatory standards by examining and analyzing records, reports, procedures and related documentation; Provide recommendations for continuous improvement to strengthen the internal processes and structure.

Responsible for documenting audit findings and monitoring corrective actions associated with the audit findings until closure.

Responsible for developing and maintaining policies and procedures for an effective and compliant internal audit program. Develop, prepare and maintain various QMS metrics and dashboards for management review and quality monitoring.

Manage and lead the lifecycle requirements for the electronic QMS.

Assist with QMS activities, such as CAPAs, non-conformance, deviations, supplier quality, complaints, process monitoring and improvement, and batch records review.

Provide training, guidance, and support to the company for QMS related policies and procedures.

Develop solutions to routine assigned activities of moderate scope and complexity.

Independently determine and develop an approach to solutions for moderate/complex problems.

Provide continuous assessment and identify areas of improvement for the QMS.

Lead process improvement projects of low/medium complexity.

Other duties as assigned.

BA/BS (or equivalent industry experience) with 5+ years of relevant experience including 3 + years of experience in the life sciences industry, preferably in an FDA medical device/IVD regulated environment.

Lead Auditor Certification is required

Strong working knowledge of FDA QMSR/cGMP and ISO 13485, ISO 14971 regulations.

Must have good verbal, written, communication and organizational skills, and be able to work in a cross-functional team environment.

Ability to perform a variety of duties involving critical thinking, analysis, evaluation, and judgment in support of QMS activities.

Ability to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.

Ability to prioritize tasks and deliver assignments with high quality in a timely manner.

Primarily desk-based work with extended periods of computer use.

Frequent typing and screen interaction

Occasional light lifting up to 10 Ibs.

Quiet to moderate noise level in an office or remote setting.

Collaborative team environment with virtual or in-person meetings.

Ability to travel approximately 10% as audit needs require