Quality Systems Specialist

TerraPower LLC.; Everett (WA); On-site; USD 117,000 - 152,000; Full time

Benefits offered by this job

Competitive compensation

Discretionary incentive payments

Comprehensive medical and wellness

Parental leave

401k plan

21 days PTO

Generous holiday schedule

Relocation assistance

Professional and educational support

Job summary

TerraPower Isotopes is seeking a seasoned Quality Systems Specialist to support Ac-225 production at the Everett, WA facility. The role focuses on establishing, developing, and maintaining robust quality systems to ensure GMP alignment, regulatory compliance, radiation safety, and adherence to company policies.

You will onboard and qualify new systems, create and optimize procedures, develop training programs, and drive key quality initiatives, collaborating with QA, Operations, Engineering,

Qualifications

• Bachelor’s degree in life sciences, engineering, or related field.
• 6+ years in a regulated production environment; 3+ years in Quality Systems.
• Pharma QA discipline, Lean Six Sigma, or PM cert a plus.
• Experience with Quality Systems and Management Review.
• Experience developing BI reports.
• Knowledge of FDA cGMP, 21 CFR 210/211 and ICH guidelines.

Responsibilities

• Author, revise, and manage policies and procedures related to Quality Systems.
• Manage onsite Quality training program and curriculum creation.
• Develop and implement data integrity policies for accuracy and compliance.
• Participate in Quality System audits and address findings.
• Support quality-driven project workstreams and continuous improvement.
• Support implementation of Quality Management Systems and 21 CFR 11 compliance.
• Provide quality training and act as a resource for inquiries.

Skills

Quality Systems

Regulatory compliance

Data integrity

Cross-functional leadership

Education

Bachelor's degree in life sciences/engineering

Tools

EDMS

LMS

QMS

Job description

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 Systems 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.

Responsibilities:

• Author, revise, and manage the approval of site policies and procedures related to Quality Systems.
• Manage the onsite Quality training program (approving content, working with stakeholders in training plan and curriculum creation, conducting the training).
• Participate in the development and implementation of data integrity policies to ensure the accuracy, reliability, and compliance of all data generated within the organization.
• 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.

Key Qualifications and Skills

• 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 and Quality Management Review.

• Experience developing or managing business intelligence reports.

• 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 documentationand 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:

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

Salary Range: 116,852 - $151,757

*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.

Benefits:

• Competitive Compensation
• Salary, eligible to participate in discretionary short-term incentive payments
• Comprehensive Medical and Wellness Benefits
  • Medical
  • Vision
  • Dental
  • Life and Disability
  • Gender Affciation Benefits
• Parental Leave
• 401k Plan
• Generous Paid Time Off (PTO)
  • 21 days of annually accrued PTO
• Generous Holiday Schedule
  • 10 paid holidays
• Relocation Assistance
• Professional and Educational Support Opportunities

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