Quality Systems Specialist

TerraPower LLC.•Everett, WA

9d•$117,922 - $176,883•Onsite

About The Position

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 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. 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. 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. Quality Assurance Specialist TerraPower Isotopes is seeking an experienced Quality Systems Specialist to support Ac-225 production at the Everett, WA manufacturing facility. The successful candidate will have experience in a quality systems role with focus on establishing, developing, and maintaining robust quality systems to ensure alignment with Good Manufacturing Practices (GMP), regulatory guidelines (FDA Title 21 CFR 210/211 and ICH Guidance), radiation safety, and company policies. This position will focus on onboarding and qualifying new systems, creating and optimizing procedures, developing training programs, and driving implementation of key quality initiatives. The Quality Systems Specialist supports the operation and maintenance of Quality Management Systems (QMS), including Electronic Document Management System (EDMS), Learning Management System (LMS) and training program, Quality Risk Management (QRM) program, and data integrity policies and will operate under stringent FDA and NRC regulations. The Quality Systems Specialist will report to the Quality Systems Manager and collaborates with a multidisciplinary team including site Quality Assurance, Operations, Quality Control, Engineering, R&D, Procurement, Project Management and Commercial Services teams to achieve company objectives.

Requirements

Bachelor’s degree in life sciences discipline, engineering, or a related field (or equivalent qualification through experience).
6+ years’ industry experience in a regulated production environment (e.g., ISO 9001, cGMP pharmaceutical or radiopharmaceutical industries), including 3+ years of prior experience in a Quality Systems role.
Demonstrated experience working within Quality Systems.
Strong working knowledge of quality principles, with proven success in managing complex projects and a wide range of responsibilities.
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.
Strong attention to detail, with the ability to interpret federal regulations, guidance and standards. Ability to incorporate relevant requirements into TPI documentation and provide guidance to personnel regarding compliance.
Must demonstrate flexibility in adjusting to changing priorities and schedules in a dynamic environment.
Strong interpersonal skills with demonstrated ability to lead cross-functional teams and drive accountability.
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.

Nice To Haves

Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma or project management training/certification is a plus.

Responsibilities

Author, revise, and manage the approval of site policies and procedures related to Quality Systems.
Participate in the development and implementation of data integrity policies to ensure the accuracy, reliability, and compliance of all data generated within the organization.
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.
Ensure data integrity compliance across quality systems, including adherence to ALCOA+ principles and 21 CFR Part 11 requirements.
Balance quality requirements with safety, such as radiation safety, in all quality activities.
Provide comprehensive, Quality-related training to colleagues within TPI and act as a resource for quality related inquiries
Perform other general duties associated with the position as required by supervision.