TITLE: Quality Assurance Engineer, Targeted Alpha Therapy
LOCATION: Everett, and Bellevue, WA, USA
TerraPower is a nuclear technology company based in Bellevue, Washington. At its core, the company is working to raise living standards globally through a more affordable, secure and environmentally friendly form of nuclear energy along with innovations in medical isotopes to improve human health. In 2006, TerraPower originated with Bill Gates and a group of like-minded visionaries who evaluated the fundamental challenges to raising living standards around the world. They recognized energy access was crucial to the health and economic well-being of communities and decided that the private sector needed to take action and create energy sources that would advance global energy deployment. TerraPower’s mission is to be a world leader in new nuclear technologies, while developing innovators and future leaders in the nuclear field. As a result, the company’s activities in the fields of nuclear energy and related sciences are yielding significant innovations in the safety and economics of nuclear power, hybrid energy and medical applications – all for significant human health benefits.
TerraPower is seeking to hire highly motivated and forward-thinking professionals who are interested in focusing on advanced nuclear reactor research and development and influencing change within the nuclear power landscape and bringing forward the critical production of medical isotopes. TerraPower is an Equal Opportunity Employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state, or local law. In addition, as a federal contractor, TerraPower has instituted an Affirmative Action Plan (AAP) in an effort to proactively recruit, hire, and promote women, minorities, disabled persons and veterans.
Quality Assurance Engineer - TAT
TerraPower seeks to survival rates, such as prostate cancer, colorectal cancer, and non-Hodgkin’s lymphoma through the supply of radioisotopes. TerraPower currently has unique access to a supply of Thorium for the long-term production of Actinium-225 for cancer treatments in the growing alpha therapy market and intends to expand into other nuclear related medical treatments. The Sr. Quality Assurance Engineer reports to the Quality Assurance Manager - Targeted Alpha Therapy (TAT) in support of this mission.
This role will support the early development of quality assurance activities of TerraPower quality (TAT) Program. They will assist in development of the Laboratory Management Information System and analytical methods/ procedures under a Quality Management System to ISO 9001 quality assurance standards and title 21 CFR 210/211 and ICH Guides.
This position is in a dynamic environment and requires the ability to maintain composure while making analyzing data and important decisions. The position will require excellent judgement and discretion in balancing compliance and business resolutions. The level for the role will be determined at time of hire based on candidate experience.
A Quality Assurance Engineer’s primary responsibility include:
- Author, revise, review and approve site procedure and policies related to Quality.
- Support the Quality Assurance System, CAPA program and follow up on CAPA actions, monitor, monitor/support supplier performance, etc.
- Participate in applicable Quality System Standards and Regulations, FDA, supplier, customer and internal audits as required.
- Review and approve Change Control/Quality Documents involving product or process changes.
- Review and approve validations (equipment, cleaning and/or process)
- QA Contact for risk management activities, including FMEA’s (Failure Modes and Effects Analysis)
- Investigate or serve as QA approver for customer complaints, deviations/out of specifications ensuring root causes and corrective actions are appropriately identified to reduce/prevent recurrence within required times frames and documented.
- Assemble, analyze and report QA data metrics to ensure regulatory compliance, identify trends and to identify areas of improvement.
- Review Batch Records and provide final product disposition
- Aide in assessing risk during Vendor Qualifications or Material Assessments
- Must demonstrate flexibility in adjusting to changing priorities and schedules.
- Assist in the training, developing, and mentoring of employees.
- Perform other general duties associated with the position as required by supervision.
Key Qualifications and Skills
- A bachelor level degree in a Science or Engineering
- 5+ years’ experience in Quality or a regulated operational production environment (e.g., ISO 9001, cGMP or nuclear industries).
- Experience working within a quality program compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance; preferably, experience in an operational / production radiopharmaceutical facility.
- Must have a keen attention to detail with the ability to read, understand requirements such as federal regulations, national codes and standards and interpret these standards into TerraPower documents and provided guidance to TerraPower personnel regarding these requirements.
- Strong organizational and communication skills, including technical writing, teamwork, and interpersonal skills and display respect and a desire to foster teamwork
- The successful candidate will possess a high degree of trust and integrity, communicate openly and display respect and a desire to foster teamwork.
Job Functions are physical actions and/or working conditions associated with the position. These functions may also constitute essential functions for the job which the employee must be able to fulfill, with or without accommodation. Information provided below is to help describe the job so that the applicant has a reasonable understanding of the job duties/expectations. 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.
- Motor Abilities: Sitting and standing for extended periods, bending/stooping, grasping/gripping, fine motor control (hands)
- Physical exertion and/or requirements: Minimal, with ability to safely lift up to 25 pounds
- Repetitive work: Prolonged
- Ability to be present as needed in a laboratory setting with fluctuating temperatures
- Special Senses: Visual and audio focused work
- Work Conditions: Stairs, typing/keyboard, standard and/or sitting working environment of >8 hrs./day
- Travel required 0-10%.
TerraPower’s technology is controlled for export by various agencies of the U.S. Government. TerraPower must evaluate applicants who are foreign nationals (other than asylees, refugees, or lawful permanent residents) in accordance with U.S. Government export control requirements. To facilitate TerraPower’s export control reviews, you will be asked as part of the application process to identify whether you are a U.S. Citizen or national, asylee, refugee, or lawful permanent resident of the United States. Government export authorization approval times vary. Based on the business needs for a particular position, TerraPower may not consider a foreign national from a country if it is impracticable to obtain timely Government export approval.
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