Radiopharma QA Specialist — GMP & CAPA Leader

Siemens Healthineers AG; Covington (LA); On-site; USD 101,000 - 139,000; 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保险

paid parking/public transportation

paid time off

paid sick and safe time

Job summary

Siemens Healthineers AG is seeking a Quality Specialist to oversee a US-based site manufacturing radioactive sterile injectables under 21 CFR Part 212 and USP 825. You will lead GMP investigations, CAPA programs, batch release reviews, and audits to ensure regulatory compliance and product quality.

The role emphasizes on-site training, mentoring, data integrity reviews, and collaboration with FDA inspections. Flexibility to travel and strong pharmaceutical QA background are preferred.

Qualifications

• Bachelor’s degree in a scientific field is preferred or equivalent experience.
• Excellent attention to detail and problem solving.
• Be able to reprioritize multiple times per day while delivering results on time.

Responsibilities

• Quality oversight of a US-based site that manufactures and distributes radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825 for Siemens Healthineers Radiopharma.
• Focus on GMP investigations and CAPA’s, change management, batch release and batch record reviews, site quality audits and data integrity audits.
• Provide on-site support for training/mentoring, performing internal and 3rd party quality audits and hosting/support FDA inspections.
• Serve as the subject matter expert on assigned topics related to policies and procedures.
• Participate in continuous improvement projects.
• Manage quality metrics at the site, including reduction of batch record corrections, investigations, failed batches due to operator error and other quality metrics.
• Internal form review, inventory management, observations of staff qualifications and facility inspection.

Skills

Quality oversight

GMP investigations

CAPA management

On-site training

Data integrity audits

Change management

Batch release

Audit execution

Regulatory compliance

Education

Bachelor’s degree in a scientific field

Tools

MS Office

Job description

Siemens Healthineers AG is seeking a Quality Specialist to oversee a US-based site manufacturing radioactive sterile injectables under 21 CFR Part 212 and USP 825. You will lead GMP investigations, CAPA programs, batch release reviews, and audits to ensure regulatory compliance and product quality.

The role emphasizes on-site training, mentoring, data integrity reviews, and collaboration with FDA inspections. Flexibility to travel and strong pharmaceutical QA background are preferred.