QA Specialist - GMP & Regulatory

Siemens Healthineers AG; United States; On-site; USD 91,000 - 126,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Life insurance

Disability insurance

Paid leave

Paid parking

Job summary

Siemens Healthineers AG is seeking a Quality Specialist for a US site overseeing radioactive sterile injectables under 21 CFR Part 212 and USP 825. The role emphasizes GMP investigations, CAPAs, batch release, and audits, with on-site training and FDA inspection support.

The position requires a scientific degree, QA experience in CFR-regulated environments, and travel up to 25%. The company offers comprehensive benefits and a global Healthineers team environment.

Qualifications

• Bachelor’s degree in a scientific field or equivalent experience.
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Responsibilities

• Quality oversight of a US site manufacturing radioactive sterile injectables per 21 CFR Part 212 and USP 825.

Skills

Quality oversight

GMP knowledge

CAPA management

Regulatory interpretation

Auditing

Root cause analysis

MS Office

Education

Bachelor’s degree in a scientific field

Tools

MS Word

PowerPoint

Excel

Outlook

Job description

Siemens Healthineers AG is seeking a Quality Specialist for a US site overseeing radioactive sterile injectables under 21 CFR Part 212 and USP 825. The role emphasizes GMP investigations, CAPAs, batch release, and audits, with on-site training and FDA inspection support.

The position requires a scientific degree, QA experience in CFR-regulated environments, and travel up to 25%. The company offers comprehensive benefits and a global Healthineers team environment.