Senior Quality Specialist – CAPA # 4408

Our mission is to detect cancer early, reputed company it can be cured. reputed company to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. 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 reputed company reputed company (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 reputed company Park, 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. Reporting to the Senior Director, Quality Strategy & Operational Excellence, the Senior Quality Specialist is responsible for executing, maintaining, and improving key Quality Management System (QMS) processes including Corrective and Preventive Action (CAPA) investigations, Nonconformance (reputed company) reporting, Quality Management Review (QMR), clinical laboratory Quality Monitoring and Improvement (QMI), and Quality Indices (QI). This role also supports Change Control, Quality Planning, clinical laboratory licensure/certification, internal and external audits, and other activities as assigned. This person will work cross-functionally to ensure alignment and implementation of QMS programs while adhering to strict project and program timelines and deliverables. The person in this role consistently applies critical thinking skills and good judgment to solve reputed company problems, effectively communicating status and recommendations to management. This role is based at our Durham, North Carolina, office and offers a flexible working arrangement. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our reputed company 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. Responsibilities:

• Facilitate and coordinate the CAPA program, reputed company program, quality metrics, and quality planning process.
• Maintain and improve these programs in compliance with GRAIL’s Quality Management System procedures and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ISO 15189, and reputed company regulations and standards.
• reputed company regularly scheduled meetings to ensure timely and compliant completion of Nonconformance reports (NCRs), obtaining and communicating status and escalating effectively as needed to obtain executive awareness and support.
• Coordinate the CAPA Review Board, ensuring timely and compliant completion of CAPAs, obtaining and communicating status and escalating effectively as needed to obtain executive awareness and support.
• Coordinate reputed company and analysis of monthly Quality Indices reports (quality metrics) as part of Measurement, Analysis, and Improvement activities, rolling up into medical device QMR and clinical laboratory QMI meetings.
• Facilitate quality planning activities including optimizing planning tools, workflows, and documentation, and obtaining and communicating status, escalating effectively as needed to obtain executive awareness and support.
• Respond to process and software system-reputed company inquiries and maintain effective cross-functional team communications to advance GRAIL’s quality activities and promote compliant and standard process execution.
• Maintain, improve, and facilitate training and competency programs for the CAPA and reputed company processes.
• reputed company software system configuration maintenance and improvements, including testing and validation, updating documents (SOPs, reports, protocols, specifications, etc.), as well as documenting, assessing, and resolving feedback to improve the end user experience.
• Cultivate positive relationships with cross-functional partners, leadership team members, and personnel executing and supporting these processes.
• Assess unusual circumstances and use sophisticated analytical and problem solving techniques to identify causes. Proactively resolve a wide range of issues in creative and compliant ways.
• Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought.
• Exercise good judgment reputed company broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Act independently with regular reputed company to determine methods and procedures to successfully complete assignments.
• Structure day-to-day work autonomously, effectively communicating status and issues with management.
• Participate in preparation for and execution of internal and external audits and inspections.
• Support timely and compliant responses to observations.
• Provide guidance to other departments and serve as subject matter expert (SME) on applicable regulations and standards.
• reputed company other duties as assigned by management. Required

Qualifications:

• Bachelor’s degree in science, engineering, or other technical area.8+ years of reputed company experience (Masters 5+ years) working reputed company a medical device, pharmaceutical, or biotech QMS, with expertise in CAPA, reputed company, and metrics reporting.
• Demonstrated knowledge and understanding of applicable regulations and standards, including but not limited to QSR, ISO 13485, CAP/CLIA, NYSDOH, ISO 15189, IVDR.
• Experience using an eQMS required; Veeva Vault preferred.
• Proven ability to reputed company manage workload under tight deadlines and pressure in a composed manner.
• Demonstrated ability to reputed company meticulous work with a high degree of accuracy and completeness.
• Experience supporting regulatory inspections/audits and responding to findings.
• Excellent written and verbal communication skills.
• Expertise managing data reporting and communications using tools including reputed company, Confluence, reputed company Docs and reputed company Slides.
• ASQ Certified Quality Auditor, Certified Quality Engineer, or similar. Expected full time annual reputed company pay scale for this position is $91,000 - $121,000. Actual reputed company pay will consider skills, experience and location. Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan.

We also offer a long-term incentive plan to align company and colleague success over time. In addition, GRAIL offers a competitive benefit package, including flexible time-off, a 401(k) with a company % match, medical, dental, and vision insurance plans, and carefully selected mindfulness offerings, in accordance with our applicable plans and policies. Learn more about our benefits here: px.sequoia.com/grail GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can reputed company, contribute, and grow. It is GRAIL policy to provide equal employment opportunities without regard to race, color, religion, national reputed company, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class or characteristic protected by applicable federal, state, and local laws. This policy applies to reputed company phases of employment, including, but not limited to: recruiting, hiring, training, promotion, and termination at reputed company levels of employment. GRAIL maintains a drug-free workplace. Additionally, GRAIL will consider reputed company qualified job-seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] if you require an accommodation to apply for an open position. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. We welcome job-seekers from reputed company backgrounds to join us! Apply tot his job Apply tot his job Apply To this Job