Radiopharma QA Specialist – GMP & CAPA (Travel)

530d PETNET Solutions, Inc.; United States; Vor Ort; USD 92.000 - 126.000; Vollzeit

Benefits dieser Stelle

medical insurance

dental insurance

vision insurance

401(k) retirement plan

life insurance

disability insurance

paid parking/public transportation

paid time off

paid sick and safe time

Zusammenfassung

Siemens Healthineers in Knoxville, TN is seeking a Corporate Quality Assurance Specialist to oversee quality activities for Production Support Lab, Technical Support Team and Implementation Team. This role supports radiopharma manufacturing in the US, ensuring compliance with 21 CFR Part 212 and USP 825.

You will review GMP investigations, CAPAs and change controls, act as the Quality System Officer, provide GMP training, and assist with audits and inspections.

Qualifikationen

• Bachelor’s degree in a scientific field (biology, chemistry, microbiology, pharmacy) or equivalent experience.
• Excellent attention to detail.
• Experience in QA: problem-solving, root cause analysis and CAPA.

Aufgaben

• Provide quality oversight of Production Support Lab, Technical Support Team and Implementation Team.
• Act as QSO for corporate teams; assist with root cause and trend analysis of technical issues.
• Review GMP investigations, CAPA and change controls.
• Serve as subject matter expert on topics and contribute to policies and decisions.
• Provide GMP training and support audits/inspections.
• Travel up to 10%.

Kenntnisse

Pharma industry

PET radiopharma

QC testing

QA discipline

Root cause analysis

Cross‑dept coordination

Microbiology/Chem

MS Office

Travel willingness

Science degree

Ausbildung

Bachelor’s degree in science

Tools

MS Office

Jobbeschreibung

Siemens Healthineers in Knoxville, TN is seeking a Corporate Quality Assurance Specialist to oversee quality activities for Production Support Lab, Technical Support Team and Implementation Team. This role supports radiopharma manufacturing in the US, ensuring compliance with 21 CFR Part 212 and USP 825.

You will review GMP investigations, CAPAs and change controls, act as the Quality System Officer, provide GMP training, and assist with audits and inspections.