Quality Assurance Specialist

Description

The medical isotopes division was set up to develop isotopes for nuclear medicine, supplying radioisotopes that support new cancer radiotherapies.

The division has long-term access to thorium for producing actinium-225, which serves the growing alpha therapy market, and plans to move into other nuclear-based medical treatments.

The company, based in Washington State, was founded in 2006 and works on new nuclear technologies while developing future leaders in the field.

This Quality Assurance Specialist role supports actinium-225 production at the Everett, WA manufacturing facility and reports to the Manager, Quality Assurance. You will work alongside Operations, Quality Control, Engineering, R&D, Procurement, Project Management and Commercial Services.

The role calls for sound judgement in balancing compliance against business needs, and experience in quality assurance covering GMP, FDA Title 21 CFR 210/211, ICH guidelines, radiation safety and company policy.

Responsibilities

• Check batch records, Certificates of Analysis and other documents for accuracy and completeness.
• Write, revise and obtain approval for site policies and procedures.
• Review and approve quality records such as deviations, change controls, CAPAs and complaints.
• Help run the supplier qualification program by confirming suppliers meet quality requirements, with a focus on critical materials, services and supplier performance.
• Provide quality support for daily production at the Everett laboratory.
• Prepare audit documents, analyze findings and carry out corrective actions for internal and external audits.
• Contribute to project work and quality-led continuous improvement.
• Help put Quality Management Systems into practice.
• Support validation and qualification of equipment, facilities and manufacturing processes.
• Maintain data integrity across quality systems, following ALCOA+ principles and 21 CFR Part 11.
• Weigh quality requirements against safety, including radiation safety.
• Train TPI colleagues on quality topics and answer their quality questions.
• Carry out other general duties as your supervisor requires.

Requirements

• Bachelor's degree in life sciences, engineering or a related field, or equivalent experience.
• 6+ years in a regulated production setting such as ISO 9001, cGMP pharmaceutical or radiopharmaceutical work, including 3+ years in a quality assurance role.
• Demonstrated experience working within quality systems.
• Solid grasp of quality principles, with a record of running complex projects and handling many responsibilities at once.
• Experience in a quality program that meets FDA and cGMP rules (Title 21 CFR 210/211) and ICH guidance.
• Ability to read federal regulations, guidance and standards, build their requirements into TPI documents and advise staff on compliance.
• High attention to detail.
• Ability to lead cross-functional teams and hold people accountable.
• Strong written and verbal communication, including technical writing and reporting to executives.
• High trust and integrity, open communication, respect and a team approach.
• Certification in a pharmaceutical quality discipline, Lean Six Sigma or project management training or certification is a plus.
• Experience in a production radiopharmaceutical facility is preferred.

Conditions

Pay falls within the posted salary band, which is set using market data and based on the selected person's qualifications and experience. The band applies to Washington State.

Flexibility is needed as priorities and schedules shift, and occasional evening or weekend work might be required to support production or project deliverables.

Physical demands include long periods of sitting, bending, stooping, gripping and fine hand control, with lifting minimal and up to 25 pounds. Repetitive work is prolonged, the work is visually and audibly focused, and you will use stairs and a keyboard in a standard seated setting for over 8 hours a day.

Travel is 0-10%.

Accommodations are considered case by case after an individual assessment, including applicable safety standards.

The company's technology is export-controlled by U.S. agencies, so foreign nationals other than asylees, refugees or lawful permanent residents must be assessed under U.S. export control rules. You will be asked during the application whether you are a U.S. citizen or national, asylee, refugee or lawful permanent resident. Approval times vary, so based on the needs of a given role, the company may not consider a foreign national from a country where timely government approval is impracticable to obtain.

Benefits

• Salary, with eligibility for discretionary short-term incentive payments.
• Medical, vision and dental coverage.
• Life and disability coverage.
• Gender affirmation benefits.
• Parental leave.
• 401k plan.
• 21 days of annually accrued paid time off.
• 10 paid holidays.
• Relocation assistance.
• Support for professional development and further education.