QA Specialist, Radiopharma GMP & CAPA Oversight

530d PETNET Solutions, Inc.; United States; In loco; USD 92.000 - 126.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid time off

Descrizione del lavoro

Siemens Healthineers seeks a QA professional to provide quality oversight for a US-based PET radiopharma site, ensuring compliance with 21 CFR Part 212 and USP 825. You will lead GMP investigations, CAPAs, batch release, and site audits while mentoring staff and supporting FDA inspections.

The role requires strong regulatory interpretation, problem-solving, and data integrity focus, with 10–25% travel. A science degree and 3–5 years QA experience in regulated pharma are essential.

Competenze

• Pharma industry experience preferred; sterile drug manufacturing and/or PET radiopharmaceuticals per 21 CFR Part 212 and Part 11.
• Experience interpreting regulatory policies and guidance documents and applying them to activities.
• Expert in QA disciplines: root cause analysis, investigation writing, and corrective and preventive actions management.
• Identify procedural gaps and product risk and recommend contingency plans to mitigate compliance.
• Completed studies in Microbiology and/or Analytical Chemistry.

Mansioni

• Provide quality oversight of a US-based site that manufactures and distributes radioactive sterile injectables (PET).
• Focus on GMP investigations and CAPAs, change management, batch release and batch record reviews, site quality audits and data integrity audits.
• Provide on-site support for training/mentoring, internal and third-party audits, and FDA inspections.
• Serve as subject matter expert on assigned topics and input on policies and procedures.
• Participate in continuous improvement projects.
• Manage quality metrics at the site, including reductions in batch record corrections, investigations, and failed batches.
• Oversee internal form reviews, inventory management, observations of staff qualifications and facility inspections.

Conoscenze

Attention to detail

Problem solving

Creativity

Analytical thinking

Formazione

Bachelor’s degree in a scientific field

Strumenti

MS Office

Descrizione del lavoro

Siemens Healthineers seeks a QA professional to provide quality oversight for a US-based PET radiopharma site, ensuring compliance with 21 CFR Part 212 and USP 825. You will lead GMP investigations, CAPAs, batch release, and site audits while mentoring staff and supporting FDA inspections.

The role requires strong regulatory interpretation, problem-solving, and data integrity focus, with 10–25% travel. A science degree and 3–5 years QA experience in regulated pharma are essential.