TerraPower.

Quality Systems Specialist

Everett, WA, USA

Sponsorship not specified$118k-$177kDetected 14 days ago

Project ManagementProcess ImprovementProcurementGMPFDA RegulatoryCommunicationWritingLean Manufacturing

About the role

TerraPower currently has unique access to a supply of thorium for the long-term production of actinium-225 in the growing alpha therapy market and intends to expand into other nuclear related medical treatments.
In 2006, the company originated with Bill Gates and a group of like-minded visionaries who evaluated the fundamental challenges to raising living standards around the world.
TPI is seeking to hire highly motivated and forward-thinking professionals who are interested in focusing on advanced radiopharmaceutical applications and influencing change within nuclear medicine.

Author, revise, and manage the approval of site policies and procedures related to Quality Systems.
Support supplier qualification program, including verifying supplier compliance with applicable quality requirements, focusing on critical materials, services, and supplier performance.
Participate in Quality System audits (supplier, customer, and internal audits). Collaborate to resolve audit findings and track follow-up actions to closure.
Support project workstreams and continuous improvement project driven by Quality.
Support implementation of Quality Management Systems.
Support development processes for validation/qualification of equipment, facility, and/or manufacturing processes.
Strong interpersonal skills with demonstrated ability to lead cross-functional teams and drive accountability.
An applicant's ability to perform and/or tolerate these actions and conditions will be discussed and workplace accommodations may be made on a case-by-case basis following an individualized assessment of the applicant and other considerations, including but not limited to any governing safety standards.

Minimal, with ability to safely lift up to 25 pounds.
These functions may also constitute essential functions for the job which the employee must be able to fulfill, with or without accommodation.
Travel required 10
Travel required 10 - 20%
Perform other general duties associated with the position as required by supervision.
Bachelor's degree in life sciences discipline, engineering, or a related field (or equivalent qualification through experience).
Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting abilities.
The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork.

Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma or project management training/certification is a plus.
Experience working within a quality program compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance.
Experience in a production radiopharmaceutical facility is preferred.

Any salary offered within the posted salary band is based on market data and commensurate with the selected individual's qualifications experience.
117,922 - $176,883
Salary, eligible to participate in discretionary short-term incentive payments

To facilitate TerraPower's export control reviews, you will be asked as part of the

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