Senior Quality Assurance Specialist

Senior Quality Assurance Specialist

TerraPower Isotopes is seeking an experienced Senior 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 Senior Quality Assurance Specialist will be a key contributor in designing quality systems to support cGMP manufacturing activities, including leading project teams to meet key quality initiatives. The Senior Quality Assurance Specialist will also 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 Senior 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.

Responsibilities:

• Lead and contribute to quality-driven project teams to support key organizational initiatives.
• Optimize current site policies and procedures to support cGMP implementation.
• Review batch records, Certificates of Analysis, and supporting documentation to accurately and efficiently disposition product batches.
• Review and approval of quality documentation, including deviations, change controls and CAPA, and complaints.
• Provide Quality Assurance support for routine production activities at the Everett Laboratory.
• Lead and participate in internal, supplier, and customer audits, and drive timely resolution of audit findings.
• Support the supplier qualification program by verifying compliance with quality requirements and monitoring performance of critical suppliers and service providers.
• 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 and compliance needs with safety requirements, including radiation safety.
• Communicate quality expectations and objectives across the organization to promote a strong quality culture.
• Deliver comprehensive quality-related training and serve as a subject-matter resource for colleagues.
• Perform additional duties as required to support Quality Assurance operations.

Key Qualifications and Skills

• Bachelor's degree in life sciences discipline, engineering, or a related field (or equivalent qualification through experience).
• 8+ 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.
• 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. 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. Occasional evening or weekend work might be required to support production operations or project deliverables.
• Strong interpersonal skills with demonstrated ability to lead internal and external 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 5-10%

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

Job Type: Full-time

Salary Range: $124,114 - $161,187

*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.

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 Affirmation 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