Quality Systems Specialist

• 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.

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

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.

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 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 hours/day
• Travel required 10 - 20%

TerraPower Isotopes' technology is controlled for export by various agencies of the U.S.

Government.

TerraPower Isotopes 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 Isotopes may not consider a foreign national from a country if it is impracticable to obtain timely Government export approval.

Job details

*We typically place offers in the lower to middle portion of the range to maintain internal equity and allow room for growth.

Any salary offered within the posted salary band is based on market data and commensurate with the selected individual's qualifications experience.

This range is specific to Washington State.

• Competitive Compensation
• Salary, eligible to participate in discretionary short-term incentive payments
• Comprehensive Medical and Wellness Benefits Medical Vision Dental Life and Disability Gender Affirmation Benefits
• Medical
• Vision
• Dental
• Life and Disability

• Parental Leave
• 401k Plan
• Generous Paid Time Off (PTO) 21 days of annually accrued PTO
• 21 days of annually accrued PTO
• Generous Holiday Schedule 10 paid holidays
• 10 paid holidays
• Relocation Assistance
• Professional and Educational Support Opportunities

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