Quality Assurance Specialist

TerraPower.•Everett, WA

22d•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 - TPI TerraPower Isotopes is seeking an experienced Quality Assurance Specialist to support Ac-225 production at the Everett, WA manufacturing facility. The successful candidate will have experience in a quality assurance role with focus on ensuring compliance with Good Manufacturing Practices (GMP), regulatory guidelines (FDA Title 21 CFR 210/211 and ICH Guidelines), radiation safety, and company policies. The Quality Assurance Specialist will support the quality assurance activities including batch and material disposition, deviations, CAPA, change controls, authoring procedures and policies, supplier qualification and performance monitoring, audits, and system implementation. The position requires excellent judgement and discretion in balancing compliance and business resolutions. The Quality Specialist will report to the Manager, Quality Assurance and work closely with a multidisciplinary team including 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 Assurance 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.
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.
Experience in a production radiopharmaceutical facility is preferred.

Responsibilities

Review batch records, Certificates of Analysis, and documentation for accuracy and completion.
Author, revise, and manage approval of site policies and procedures.
Review and approval of quality documentation, including deviations, change controls and CAPA, and complaints.
Support supplier qualification program, including verifying supplier compliance with applicable quality requirements, focusing on critical materials, services, and supplier performance.
Provide Quality support for ongoing production activities at Everett Laboratory.
Support internal and external audits by preparing documentation, analyzing findings, and implementing corrective actions.
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.