Quality Assurance Engineer, TerraPower Isotopes®

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TerraPower

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Everett, WA, United States

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TITLE:Quality Assurance Engineer, TerraPower Isotopes®

LOCATION:Everett, WA, USA

The TerraPower Isotopes® (TPI™) division has been established to pursue medical isotopes development-advancing nuclear science for significant human health benefits. We seek to support revolutionary radiotherapies for treatments of various cancers through the supply of radioisotopes. 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.

The TerraPower Isotopes (TPI) program is an integral part of the Washington State based TerraPower team, a company working to raise living standards globally. 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. TerraPower’s mission is to be a world leader in new nuclear technologies, while developing innovators and future leaders in the nuclear field.

TerraPower 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. 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) to proactively recruit, hire, and promote women, minorities, disabled persons and veterans.

Quality Assurance Engineer, TerraPower Isotopes®

TPI is seeking a Quality Assurance Professional to join a group of highly motivated and forward-thinking professionals in developing a system to isolate unique radioisotopes intended for use in targeted cancer therapy. The successful candidate will be a key contributor in designing a quality assurance program for this initiative, including development of a Quality Management System and implementation of a LIMS system. The position requires excellent judgement and discretion in balancing compliance and business resolutions.

Responsibilities

  • Contribute to development and implementation of the Quality Program for TPI. Author, revise, and manage the approval of site procedures and policies related to Quality.
  • Provide Quality-related training to colleagues involved in the TPI enterprise.
  • Initiate risk-management activities and involvement in risk-based decision making. Balance the requirements for safety, such as radiation safety, in all quality initiatives.
  • Support the Quality Assurance CAPA system; assist in developing corrective actions; monitor implementation.
  • Develop and implement a supplier qualification program. Monitor supplier performance.
  • Participate in Quality system audits (supplier, customer, and internal audits) as required. Contribute to resolution of audit findings and follow up.
  • Key contributor to Change Control involving product or process changes.
  • Develop processes for validation/qualification of equipment, cleaning, and/or manufacturing processes. Review and approve results.
  • Assemble, analyze, and report QA data metrics to detect trends and identify areas for improvement.
  • Perform other general duties associated with the position as required by supervision.

Key Qualifications and Skills

  • Bachelor’s level degree in Science or Engineering
  • 3+ years’ experience in Quality or a regulated operational production environment (e.g., ISO 9001, cGMP or radiopharmaceutical 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.
  • Certification in a Pharmaceutical Quality-related discipline a plus.
  • Must have keen attention to detail with the ability to read and understand requirements such as federal regulations, national codes and standards. Interpret these standards into TPI documents and provide guidance to personnel regarding these requirements.
  • Strong organizational and communication skills, including technical writing, teamwork and interpersonal skill.
  • Prior experience in pharmaceutical Quality Assurance is required, and related certification(s) is a plus.
  • Familiarity with ISO 9001 Quality Assurance standards, 21 CFR 210/211 regulations and ICH Guides.
  • Must demonstrate flexibility in adjusting to changing priorities and schedules in a dynamic environment.
  • Actual position starting level and title will be determined based on assessment of qualifications.
  • Military experience is a plus
  • 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

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/or 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
  • Special Senses: Visual and audio focused work
  • Work Conditions: Stairs, typing/keyboard, standard and/or sitting working environment of >8 hrs./day
  • Travel required: 0-5%

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.

Job details

Salary Range Level 8: $81,383 - $122,075

Salary Range Level 9: $95,415 - $143,122

  • Typically, our employee salaries are within .90 – 1.0 of the mid-point of the posted salary bands. Any salary offered within the posted salary band is based on market data and commensurate with the selected candidate’s qualifications and experience. This range is specific to Washington State.

Benefits:

  • Competitive Compensation
  • Salary, eligible to participate in discretionary short-term incentive payments
  • Comprehensive Medical and Wellness Benefits Medical
  • Vision
  • Dental
  • Life
  • Life and Disability
  • Gender Affirmation Benefits
  • Parental Leave
  • 401k Plan
  • Generous Paid Time Off (PTO)
  • 21 days of annually accrued PTO
  • Generous Holiday Schedule
  • 10 paid holidays
  • Relocation Assistance
  • Professional and Educational Support Opportunities
  • Flexible Work Schedule

TerraPower Career and Benefits information: https://www.terrapower.com/contact-us/careers/