GRAIL
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured.
Raleigh-Durham, NC

Sr Quality Engineer, Medical Device/IVD (Material Inspection, Facilities, & Equipment) - RTP

| Raleigh-Durham, NC
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GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

The Staff Quality Engineer will act as a key liaison for quality with Material Inspection, and Facility Operations, and Equipment Engineering. This individual will be responsible for process execution to Current Good Manufacturing Practices (cGMPs), GCP, ISO 13485, FDA 21 CFR part 820, and an understanding of CLIA, CAP, and New York State Licensures. Support/complete Material Management and receipt of incoming materials requiring CoA review, Facilities and Equipment Lifecycle. Experience with Quality Systems associated with Material Inspection, Facilities and Equipment. This position is required to be onsite at RTP (North Carolina).

You will:

  • Quality SME for Equipment and Facility Program and provide QA support during manufacturing/laboratory operations, which may include shift coverage.
  • Review and approve incoming materials to release to the Clinical Laboratory.
  • Ensure timely review and closures of non-conformances (NCR’s) and CAPA’s.
  • Review/Write procedures for the QMS related to operations, equipment, material management etc.
  • Develop, implement, and conduct a Quality operations training program (Receiving inspection, Sampling methodology, investigation, etc)
  • Attend all material management meetings, including MRC and be single point of contact for materials related issues
  • Equipment and Facility failures investigations and material impact/containment (RTP)
  • Performs technical assessments and Quality approval of deviations, incident reports, non-conformances, CAPAs and investigations for commercial and clinical products.
  • Change Control support as required (reviews and approvals)
  • Process Improvements and Validation support for RTP and MPK as required
  • Backup support for existing QE
  • Participate in risk assessment and / or Failure Mode and Effects Analysis activities for both process and manufacturing FMEAs.
  • Define and implement, as appropriate, quality standards, systems, and metrics for commercial operations.
  • Present metrics for areas of responsibility to senior management.
  • Participate in preparation for and execution of internal or external audits. Ensures audit observations are addressed appropriately and completed on schedule.
  • Manage review of product release and data, Quality lead for method transfers and validations.
  • Support Quality Management Reviews and periodic product reviews
  • Support the development, implementation, and revision of corporate quality systems.
  • Participate in continuous improvement strategy which aligns to the business strategy and operational strategy while taking into account present operational realities.
  • Participate in developing and setting operational KPI’s and drive improvements

Your background and qualifications will include:

  • BA/BS and a minimum of 5 years in Quality Assurance.
  • Chemistry or Biology background preferred
  • Minimum of 3 years in Quality Operations at an FDA-regulated medical device or pharmaceutical company.
  • Project management experience preferred
  • IVD experience (reagents and assays)
  • Method validation and process validation
  • Proven experience in Change Control, CAPAs.
  • Demonstrated success engaging teams and partners for collaboration in advancing quality operations outcomes in business and quality leadership.
  • Ability to intake and process large quantities of information and subsequently make concise and timely decisions.
  • Ability to communicate above and below level in a way that fosters positive relationship building.
  • Proven knowledge of GxP regulations, quality systems, and regulatory guidance documents in the US and EU.
  • Demonstrated flexibility and advancement within a fast-paced environment.
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view.
  • Excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities.

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

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What are GRAIL Perks + Benefits

GRAIL Benefits Overview

We’re committed to creating the best experience for everyone at GRAIL, ensuring that each member of our team has comprehensive benefits and resources to thrive at all stages of life, both at work and at home.

Culture
Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Unconscious bias training
Diversity manifesto
Mean gender pay gap below 10%
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Onsite Gym
Team workouts
Retirement & Stock Options Benefits
401(K)
Company Equity
Performance Bonus
Child Care & Parental Leave Benefits
Child Care Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Family Medical Leave
Company sponsored family events
Vacation & Time Off Benefits
Unlimited Vacation Policy
Paid Holidays
Paid Sick Days
Perks & Discounts
Casual Dress
Commuter Benefits
Free Daily Meals
Game Room
Happy Hours
Parking
Professional Development Benefits
Job Training & Conferences
Diversity Program
Cross functional training encouraged
Promote from within
Mentorship program
Online course subscriptions available

An Insider's view of GRAIL

How does your team reward individual success?

People grow their skills both by learning how to rapidly build scalable software systems, but also by partnering with scientists and other domain experts to better understand, model, and envision the systems we will need. We enable and empower our engineers to lead this process and grow with our systems as they make the future of GRAIL a reality.

Tristan Matthews

Senior Director, Software Engineering

What projects are you most excited about?

GRAIL has a unique opportunity to scale our operations to add value with our early detection test. Our automation team works on the full spectrum of projects from low-level instrument investigations to overall architectures of processing facilities. I'm excited by projects that push the boundaries of lab automation, and that's what GRAIL is doing.

David Jenions

Principal Automation Engineer

What does career growth look like on your team?

Our mission, to detect cancer early, is truly seeking a needle in many haystacks. Our lab has a very complex and sophisticated assay to execute. We leverage cross-training and mentorship programs where new teammates learn the ropes from senior staff. My team sets people up for success by turning tasks into learning opportunities.

Maryam Hosseini

Director, Laboratory Operations

How do your team's ideas influence the company's direction?

The biological problem we're trying to solve is a complex machine learning problem with human lives at stake. From a software engineering point of view, taking massive data, organizing it, building tools to mine it, and deliver results in a scalable, secure, and clinically compliant manner are areas of innovation. This, for me, is my dream job!

Satnam Alag

SVP, Software Engineering

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