Quality Systems Specialist
About The Position
TerraPower Isotopes (TPI) is seeking an experienced Quality Systems Specialist to support actinium-225 production at its manufacturing facility in Everett, Washington. The role focuses on establishing, developing, and maintaining quality systems aligned with Good Manufacturing Practices (GMP), FDA regulations (Title 21 CFR 210/211), ICH guidance, radiation safety requirements, and company policies. The specialist supports the operation and maintenance of Quality Management Systems, including the Electronic Document Management System (EDMS), Learning Management System (LMS) and training program, Quality Risk Management program, and data integrity policies. Key areas of focus include onboarding and qualifying new systems, developing and optimizing procedures, creating training programs, and implementing quality initiatives. The position operates under FDA and NRC regulations and reports to the Quality Systems Manager. The specialist collaborates with Quality Assurance, Operations, Quality Control, Engineering, R&D, Procurement, Project Management, and Commercial Services teams.
Requirements
- Bachelor’s degree in a life sciences discipline, engineering, or a related field, or equivalent qualification through experience.
- At least 6 years of industry experience in a regulated production environment, including at least 3 years of prior experience in a Quality Systems role.
- Demonstrated experience working within Quality Systems and Quality Management Review.
- Strong working knowledge of quality principles, with a track record of managing complex projects and a wide range of responsibilities.
- Experience in a quality program compliant with FDA/cGMP requirements, including Title 21 CFR 210/211 and ICH guidance.
- Strong attention to detail and ability to interpret federal regulations, guidance, and standards; incorporate relevant requirements into documentation and advise personnel on compliance.
- Flexibility to adjust to changing priorities and schedules in a dynamic environment.
- Strong interpersonal skills and demonstrated ability to lead cross-functional teams and drive accountability.
- Excellent written and verbal communication skills, including technical writing and executive-level reporting abilities.
- High degree of trust and integrity, open communication, respect, and commitment to teamwork.
- Ability to safely lift up to 25 pounds.
- Ability to perform work involving prolonged repetitive activity, extended sitting, bending or stooping, grasping or gripping, and fine motor control; visual and audio focused work; stairs; and typing or keyboard use.
- Ability to work in a standard and/or sitting work environment for more than 8 hours per day.
- Ability to travel 10–20%.
Nice To Haves
- Certification in a pharmaceutical Quality-related discipline.
- Lean Six Sigma training or certification.
- Project management training or certification.
- Experience developing or managing business intelligence reports.
- Experience in a production radiopharmaceutical facility.
Responsibilities
- Author, revise, and manage approvals for site policies and procedures related to Quality Systems.
- Manage the onsite Quality training program, including approving content, collaborating with stakeholders on training plans and curricula, and conducting training.
- Participate in developing and implementing data integrity policies to ensure the accuracy, reliability, and compliance of organizational data.
- Participate in supplier, customer, and internal Quality System audits; collaborate to resolve findings and track follow-up actions through closure.
- Support Quality-driven project workstreams and continuous improvement projects.
- Support implementation of Quality Management Systems.
- Support development of validation and qualification processes for equipment, facilities, and 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, including radiation safety, in quality activities.
- Provide Quality-related training to TPI colleagues and respond to quality-related inquiries.
- Perform other general duties associated with the position as required by supervision.
Benefits
- Competitive compensation.
- Eligibility to participate in discretionary short-term incentive payments.
- Medical benefits.
- Vision benefits.
- Dental benefits.
- Life and disability benefits.
- Gender affirmation benefits.
- Parental leave.
- 401(k) plan.
- 21 days of annually accrued paid time off.
- 10 paid holidays.
- Relocation assistance.
- Professional and educational support opportunities.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
