Senior QA Specialist – GMP & Audits

Orano Med, LLC.; Brownsburg (IN); On-site; USD 75,000 - 98,000; Full time

Benefits offered by this job

Competitive compensation

Health, Dental, and Vision insurance -

401(k) with employer matching

Life insurance

Short- and Long-Term Disability

Generous Paid Time Off

Training and Development opportunities

Job summary

Orano Med, LLC. is hiring a QA Specialist III to ensure products and processes meet quality standards and regulatory requirements.

The role supports production and QC testing by performing audits, reviewing documentation, and leading investigations into deviations and CAPA. You will work with cross-functional teams to support quality initiatives, train new personnel, and assist in qualification and validation activities, maintaining rigorous records and responding to quality concerns in a timely

Qualifications

• Bachelor's degree in a scientific or technical discipline preferred.
• Four+ years of experience in a regulated industry (pharma/biotech/medical devices).
• Strong understanding of GMP, GLP, and related quality standards.
• Excellent written and verbal communication and attention to detail.

Responsibilities

• Monitor compliance with internal procedures, standards, and regulatory requirements.
• Perform audits, inspections, and product reviews.
• Author and approve batch records and quality docs.
• Lead investigations for deviations and CAPA.
• Coordinate cross-functional quality initiatives and training.
• Lead internal and partner audits and support external inspections.
• Maintain records compliant with company policies and regulations.

Skills

GMP knowledge

GLP knowledge

Quality systems

Documentation

Attention to detail

Communication

Team collaboration

Problem solving

Education

Bachelor's degree in scientific/technical field

Tools

Microsoft Office

Job description

Orano Med, LLC. is hiring a QA Specialist III to ensure products and processes meet quality standards and regulatory requirements.

The role supports production and QC testing by performing audits, reviewing documentation, and leading investigations into deviations and CAPA. You will work with cross-functional teams to support quality initiatives, train new personnel, and assist in qualification and validation activities, maintaining rigorous records and responding to quality concerns in a timely