GMP QA Specialist – Radiopharma & CAPA Expert

Siemens Healthineers AG; Covington (GA); 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

Disability insurance

Paid time off

Paid parking/public transportation

Job summary

Siemens Healthineers is seeking a Quality Specialist to oversee a US-based site manufacturing radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825. You will drive GMP investigations, CAPA management, batch release reviews, and site quality audits while training staff and supporting FDA inspections.

The role requires a strong QA background in regulated environments, root-cause analysis skills, and flexibility to travel 10–25%.

Qualifications

• Bachelor's degree in a scientific field preferred or equivalent experience required.
• Excellent attention to detail.
• Be a creative problem solver with the ability to reprioritize multiple times per day while working at the speed of business and delivering results on time.
• Willing to travel 10% - 25%.
• Relevant QA experience for 3-5 years in a 21 CFR Part 211 or 212 regulated industry.

Responsibilities

• Provide Quality oversight of a US based site that manufactures and distributes radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825.
• 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 providing input on policies, procedures and decisions.
• 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

Attention to detail

Problem solving

Root cause analysis

Regulatory interpretation

Travel availability

Education

Bachelor's degree in a scientific field

Tools

MS Office

Job description

Siemens Healthineers is seeking a Quality Specialist to oversee a US-based site manufacturing radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825. You will drive GMP investigations, CAPA management, batch release reviews, and site quality audits while training staff and supporting FDA inspections.

The role requires a strong QA background in regulated environments, root-cause analysis skills, and flexibility to travel 10–25%.