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GRAIL is seeking a Staff Associate Scientist (SAS) for the MSAT Reagent QC group in RTP, NC. This position is to support Reagent QC testing and laboratory management in a GMP laboratory setting. The Reagent QC laboratory utilizes several QC methods including NextGen Sequencing, physical property and quantitative methods to QC reagents, all of which the SAS will be expected to become an assay SME. This role also requires the ability to support/manage all aspects of Reagent QC testing including testing, data trending, scheduling, result review and troubleshooting. The SAS will also be required to have input into laboratory improvements and be able to execute implementation of any improvements into laboratory processes.

The SAS will strive to be a mentor to laboratory personnel encouraging their growth professionally as the position may transition into personnel management as well. This position will also heavily work with QA in all aspects of Reagent QC testing including document review, filing non-conformances, executing required aspects of Change Controls and contributing to document writing in support of laboratory activities. The SAS position will also require coordination of laboratory maintenance activities with the Facilities and Engineering groups following GMP guidelines.

Job Requirements;

The onsite role requires 5 days a week in RTP, NC.

This is a full time position working in our lab between the hours of 8:00 AM to 5:00 PM, Monday through Friday

Responsibilities;

• Subject Matter Expert for all Reagent QC assays performed

• Validate and retain proficiency on all Reagent QC testing processes

• Maintain laboratory equipment and maintenance schedules

• Work cross functionally to prioritize reagent testing to support Clinical lab needs

• Work cross functionally with manufacturing group

• Review operator Reagent QC assays to ensure validity of results

• Work with operators to troubleshoot reagent QC assay issues

• Contribute to laboratory improvement planning (process, software, equipment, etc.)

• Work cross functionally with other groups on reagent related projects

• Present laboratory health data in cross functional meetings

• Collaborate with R&D in support of reagent development activities

• Represent Reagent QC group in site related activities as needed

Preferred Qualifications;

• BS with 15+ years experience or MS with 10+ years of experience working in a production laboratory environment

• Experience in a GMP laboratory environment or equivalent is preferred

• 8+ years experience performing Reagents QC

• 4+ years experience with NGS platforms and processes

• Experience with technical writing a plus

• Personnel Management a plus

Physical Demands & Working Environment;

• Hours and days may vary depending on operational needs.

• Working with dry ice may be necessary.

• Standing or sitting for long periods of time may be necessary.

• May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation.

• Repetitive manual pipetting may be necessary.

• Some lifting (up to 25 pounds) may be necessary

GRAIL is an Equal Employment 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 (https://grail.com/about/#contact-us) to request accommodation. GRAIL maintains a drug-free workplace.