GMP Quality Assurance Analyst — Compliance & Audits

Evonik; Lafayette (IN); Presencial; USD 65 000 - 86 000; Tempo integral

Resumo da oferta

Evonik in Lafayette, IN is seeking a QA specialist to ensure daily manufacturing operations comply with cGMP and ISO 9001. You will mentor the Assistant QA representative and support audit readiness.

You will review deviations, change controls, validations, and master production records, working with Operations and Regulatory teams. The role requires 3–5 years in GMP environments and strong problem-solving skills. This is a collaborative, growth-oriented position.

Qualificações

• 3–5 years of industrial GMP experience preferred.
• Understand GMP regulations and applications.
• Experience with change controls, deviation investigations, and validation docs.
• Able to apply compliance standards to daily production situations.
• Good written and verbal communication skills.
• Proficient with MS Office; SAP/TrackWise experience is a plus.

Responsabilidades

• First point of contact for production issues and compliance questions.
• Provide or approve initial assessments for all quality events.
• Collaborate with Operations, then review and approve minor deviations and change controls.
• Review validation documents.
• Disposition all GMP API and final intermediate batches produced; support auto-disposition of non-final intermediates.
• Ensure adherence to the site cleaning program.
• Approve Master Production Records.
• Review and approve process start-up activities and provide oversight for audits and inspections.
• Support continuous improvement projects and participate in new standards implementation.

Conhecimentos

GMP experience

Quality mindset

Strong communication

Problem solving

Team collaboration

Microsoft Office

Formação académica

BS in chemistry, engineering, or science

Ferramentas

SAP

TrackWise

Microsoft Office

Descrição da oferta de emprego

Evonik in Lafayette, IN is seeking a QA specialist to ensure daily manufacturing operations comply with cGMP and ISO 9001. You will mentor the Assistant QA representative and support audit readiness.

You will review deviations, change controls, validations, and master production records, working with Operations and Regulatory teams. The role requires 3–5 years in GMP environments and strong problem-solving skills. This is a collaborative, growth-oriented position.