Senior QA Specialist: GMP & Compliance Lead

Orano USA; Brownsburg (IN); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Health, Dental, Vision insurance – +em

401(k) with employer matching

Life Insurance

Paid Time Off

Training and Development opportunities

Job summary

Orano Med in Brownsburg, IN, seeks a QA Specialist III to ensure products and processes meet rigorous quality standards and regulatory requirements. The role supports production and QC testing operations by performing audits, reviewing documentation, investigating deviations, and driving continuous improvement across the site.

You will lead internal audits, coordinate CAPA, mentor new personnel on QA procedures, prepare batch records, and collaborate with cross-functional teams to resolve

Qualifications

• Bachelor’s degree in scientific or technical discipline required; four+ years in a regulated industry preferred.
• Strong understanding of GMP, GLP, and other quality standards.
• Proficiency with quality management systems and MS Office suite.
• Excellent written and verbal communication skills in English.

Responsibilities

• Audit production and QC documentation to ensure compliance.
• Review batch records and procedures; approve quality-related docs.
• Lead investigations for non-conformances, deviations, and CAPA.
• Coordinate site internal audits and support external inspections.
• Train new personnel on QA procedures and best practices.
• Support qualification and validation activities for equipment, systems, and processes.

Skills

GMP compliance

Auditing

Documentation review

CAPA

Cross-functional collaboration

QA leadership

Attention to detail

Communication in English

Education

Bachelor’s degree in scientific or technical discipline

Tools

Quality Management Systems

Microsoft Office Suite

Microsoft Outlook

Job description

Orano Med in Brownsburg, IN, seeks a QA Specialist III to ensure products and processes meet rigorous quality standards and regulatory requirements. The role supports production and QC testing operations by performing audits, reviewing documentation, investigating deviations, and driving continuous improvement across the site.

You will lead internal audits, coordinate CAPA, mentor new personnel on QA procedures, prepare batch records, and collaborate with cross-functional teams to resolve