GRAIL
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured.
Hybrid

Quality Engineer (Medical Device/ IVD) - RTP

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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.


This individual is responsible for establishing/updating/executing cGMP Quality Operation activities including Reagent Production, Change Control, Deviation Management, CAPA/NCR 

You will:

  • Compile, organize, and present metrics for areas of responsibility to senior management.
  • Drive initiation, execution, closure, and trending of NCR's, Change Controls, DAR’s, CAPAs, and Line Clearances in support of Manufacturing Operation.
  • Conducting Quality reviews of production documentation, including production batch records, analytical records, and any supporting documentation to ensure compliance with cGMPs and GRAIL policies and procedures, and in some cases prepare disposition documentation.
  • Performing routine reviews of all cGMP documentation, to include laboratory notebooks, equipment logs, and facility monitoring reports. Additionally, create and/or use various databases to track compliance issues and their resolution.
  • Providing QA support during manufacturing/laboratory operations, which may include shift coverage.
  • Assist with investigation and resolution of cGMP or procedural compliance gaps, as well as work with staff from other departments to resolve compliance issues found during the Quality reviews.
  • Assist with training of personnel, to ensure compliance and conformance to GRAIL requirements.
  • Assist with Quality audits of internal departments, as well as external potential and/or current vendors, contract organizations and regulatory authorities.
  • Assists with developing, reviewing, revising and maintaining quality assurance protocols/methods/procedures for processing materials into partially finished or finished products.
  • Assist with designing methods/procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
  • Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
  • May assure compliance to in-house and/or external specifications and standards, (i.e. GLP, GMP, ISO, Six Sigma).
  • May assist/support in Quality Systems activities including Documentation Control, Training, Supplier Management, and Raw Material/Product Release.

Your background and qualifications will include:

  • Bachelor’s degree or higher in a relevant scientific area is strongly preferred
  • 1+ years relevant experience
  • Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
  • Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
  • Results dedicated with a “can do” positive attitude
  • Knowledge and ability to sufficiently train others on regulatory compliance issues
  • Strong interpersonal skills and ability to work with others in a positive and collaborative manner
  • Strong verbal and written communication skills essential
  • Strong communication, prioritization, and organizational skills
  • Knowledge of cGMP concepts and guidelines, as well as good documentation practices
  • Ability to utilize multiple word-processing and database applications.
  • Experience with contract manufacturing operations is a plus.

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
Volunteer in local community
Partners with nonprofits
Intermountain Healthcare
Open door policy
OKR operational model
Team based strategic planning
Open office floor plan
Employee resource groups
Employee-led culture committees
Hybrid work model
In-person all-hands meetings
Employee awards
Flexible work schedule
Remote work program
Diversity
Dedicated diversity and inclusion staff
Mandated 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 insurance
Vision insurance
Health insurance
Life insurance
Wellness programs
Access to the apps like CALM, empowerDX, Progyny, Happify, Spring Health, iPrevail, and more
Team workouts
Team workouts and access to ClassPass
Mental health benefits
Number of wellness programs to include:
Abortion travel benefits
Financial & Retirement
401(K)
401(K) matching
Effective 2023 GRAIL will match up to 3k
Company equity
Performance bonus
Pay transparency
Child Care & Parental Leave Benefits
Childcare benefits
Generous parental leave
Family medical leave
Company sponsored family events
Fertility benefits
Vacation & Time Off Benefits
Unlimited vacation policy
Paid holidays
Paid sick days
Flexible time off
Bereavement leave benefits
Company-wide vacation
Office Perks
Commuter benefits
Company-sponsored outings
Free daily meals
Free snacks and drinks
Drinks and snacks available
Some meals provided
Company-sponsored happy hours
Onsite office parking
Recreational clubs
Relocation assistance
Onsite gym
Professional Development Benefits
Job training & conferences
Promote from within
Mentorship program
Online course subscriptions available

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