Quality Systems Specialist, Radiopharma GMP

TerraPower LLC.; Everett (WA); Sur place; USD 117 000 - 152 000; Plein temps

Avantages offerts par ce poste

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

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality Systems

Regulatory compliance

Data integrity

Cross-functional leadership

Formation

Bachelor's degree in life sciences/engineering

Outils

EDMS

LMS

QMS

Description du poste

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,