On-Site QA Specialist — Radiopharma GMP & CAPA

Regulatory Jobs; United States; 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

paid parking/public transportation

paid time off

paid sick and safe time

Job summary

Siemens Healthineers seeks a Quality Specialist to oversee a US site manufacturing radioactive sterile injectables per 21 CFR Part 212 and USP 825. You will lead GMP investigations, CAPA, change management, and batch record reviews, while supporting FDA inspections and audits.

Ideal candidates have 3–5 years QA in a regulated setting, strong root cause analysis, and travel 10–25%. The role emphasizes problem solving and training across a global healthtech leader.

Qualifications

• Bachelor’s degree in a scientific field or equivalent experience.
• 3–5 years QA experience in a regulated industry.
• Strong root cause analysis and investigative writing skills.
• Ability to interpret regulatory policies and apply them correctly.
• Willing to travel 10–25%.

Responsibilities

• Provide quality oversight of a US site manufacturing radioactive sterile injectables per 21 CFR Part 212 and USP 825.
• Lead GMP investigations, CAPA, change management, and batch record reviews.
• Perform internal and third-party quality audits and support FDA inspections.
• Serve as SME on assigned topics for policies and procedures.
• Manage quality metrics and drive continuous improvements.
• Support training and on-site mentoring.

Skills

GMP Investigations

CAPA Management

Root Cause Analysis

Audits

Data Integrity

Training & Mentoring

FDA Inspections

Regulatory Knowledge

Problem Solving

Travel Flexibility

Education

Bachelor's degree in a scientific field

Equivalent Experience

Tools

MS Office

Word

PowerPoint

Excel

Outlook

Job description

Siemens Healthineers seeks a Quality Specialist to oversee a US site manufacturing radioactive sterile injectables per 21 CFR Part 212 and USP 825. You will lead GMP investigations, CAPA, change management, and batch record reviews, while supporting FDA inspections and audits.

Ideal candidates have 3–5 years QA in a regulated setting, strong root cause analysis, and travel 10–25%. The role emphasizes problem solving and training across a global healthtech leader.