Quality Assurance Specialist - TPI

Company: TerraPower
Location: Everett
Posted on: August 7, 2022

Job Description:

TITLE: Quality Assurance Specialist - TPI LOCATION: Everett, WA, USA The TerraPower Isotopes - (TPI---) division has been established to pursue medical isotopes developmentadvancing 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 Specialist - TPI 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. ResponsibilitiesContribute 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.Assist in Laboratory Information Management System implementation.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 Engineering1-2+ 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.Ability to obtain certification in a Pharmaceutical Quality-related discipline.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 plusThe successful candidate will possess a high degree of trust and integrity, communicate openly and display respect and a desire to foster teamwork Job FunctionsJob 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 poundsRepetitive work: ProlongedSpecial Senses: Visual and audio focused workWork Conditions: Stairs, typing/keyboard, standard and/or sitting working environment of > 8 hrs./dayTravel required: 0-5%

Keywords: TerraPower, Everett , Quality Assurance Specialist - TPI, Other , Everett, Washington