Quality Engineer (Medical Device/ IVD) - RTP
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.