Quality Systems Specialist

Quality Systems Specialist

Terra Power 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.
• 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 work streams 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.
• 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.
• 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:

• 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%