Senior QA Specialist: GMP Compliance & Investigations

Orano; Brownsburg (IN); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Competitive compensation

Health, Dental, and Vision insurance

401(k) with employer matching

Life insurance and Disability coverage

Generous Paid Time Off and holidays

Training and Development opportunities

Job summary

Orano Med is seeking a Quality Assurance Specialist to ensure products and processes meet regulatory standards. You will support production and QC testing, perform audits, review documentation, investigate deviations, and drive continuous improvement across the site.

Responsibilities include leading internal audits, handling CAPA activities, coordinating training, and maintaining records in alignment with GMP and FDA/ISO requirements.

Qualifications

• Bachelor’s degree in scientific or technical discipline preferred.
• Four plus years of experience in a regulated industry (pharma, biotech, medical devices, food).
• Experience with GMP/GLP and quality standards.

Responsibilities

• Audit production and QC processes and review deviations.
• Author, review and approve batch records and SOPs.
• Lead investigations for non-conformances and CAPA actions.
• Collaborate with cross-functional teams to support quality initiatives.
• Lead site internal and customer audits and support regulatory inspections.

Skills

GMP/GLP knowledge

Attention to detail

Quality systems

Strong communicator

Team collaboration

MS Office proficient

Education

Bachelor’s degree in scientific or technical discipline

Tools

Quality Management System (QMS)

Microsoft Office

Job description

Orano Med is seeking a Quality Assurance Specialist to ensure products and processes meet regulatory standards. You will support production and QC testing, perform audits, review documentation, investigate deviations, and drive continuous improvement across the site.

Responsibilities include leading internal audits, handling CAPA activities, coordinating training, and maintaining records in alignment with GMP and FDA/ISO requirements.