Radiopharma QA Specialist - GMP & CAPA Expert

Siemens Medical Solutions USA, Inc.; United States; On-site; USD 92,000 - 126,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term and short-term disability

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Siemens Healthineers USA seeks a Corporate Quality Specialist based in Knoxville, TN. You will provide quality oversight for the Production Support Lab, Technical Support Team, and Implementation Team supporting US radiopharma sites, ensuring compliance with 21 CFR Part 212 and USP 825.

The role emphasizes quality system stewardship, root cause and trend analysis, investigations, CAPA management, and cross-functional training. Travel up to 10% may be required for audits and projects.

Qualifications

• Experience in the pharmaceutical industry and radiopharma per 21 CFR Part 212 and Part 11 and/or USP 825.
• At least 3 years of radiopharmaceutical manufacturing experience and 3 years of QC testing for radiopharmaceuticals.
• Quality assurance disciplines: problem-solving, root cause analysis, investigation writing, and CAPA management.
• Identify procedural gaps and product risk and propose contingency plans to mitigate compliance.
• Coordinate between departments to ensure tasks are on track and compliant.
• Studies in Microbiology and/or Analytical Chemistry or related technical field.
• Proactive schedule management to complete responsibilities on time.
• Willing to travel 10%.

Responsibilities

• Provide Quality oversight of Production Support Lab, Technical Support Team, and Implementation Team for US radiopharma sites per 21 CFR Part 212 and USP 825.
• Act as the Quality System Officer (QSO) for the listed corporate teams.
• Assist Corporate Quality with root cause analysis and trend analysis to support GMP investigations and CAPAs.
• Review GMP-related investigations, CAPAs, change controls for technical accuracy.
• Serve as SME on assigned topics, contributing to policies and decisions.
• Participate in continuous improvement and trend analysis projects.
• Review qualifications and documentation, provide GMP training, and support audits and inspections.
• This role is based in Knoxville, TN and is not remote.

Skills

Quality oversight

Root cause analysis

GMP investigations

CAPA management

Cross-functional coordination

MS Office

Travel willing

Education

Bachelor’s degree in science

Tools

MS Office

Job description

Siemens Healthineers USA seeks a Corporate Quality Specialist based in Knoxville, TN. You will provide quality oversight for the Production Support Lab, Technical Support Team, and Implementation Team supporting US radiopharma sites, ensuring compliance with 21 CFR Part 212 and USP 825.

The role emphasizes quality system stewardship, root cause and trend analysis, investigations, CAPA management, and cross-functional training. Travel up to 10% may be required for audits and projects.