GMP QA Analyst - Compliance & Improvement

Evonik; Lafayette (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Evonik Corporation in Lafayette, Indiana seeks a QA Compliance professional to ensure daily manufacturing operations meet cGMP and ISO 9001 requirements. The role mentors the Assistant QA representative and supports audits and regulatory readiness.

Ideal candidates hold a BS in chemistry, engineering, or related field with 3–5 years GMP experience, demonstrating change controls, deviation investigations, and validation documentation. Strong communication and 24/7 coverage readiness are essential.

Qualifications

• BS in chemistry, engineering, science, or equivalent experience.
• 3-5 years industrial experience in a GMP environment with good technical understanding of GMP regulations.

Responsibilities

• 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 in the production area and support auto-disposition of non-final intermediates.
• Ensure adherence to site cleaning program.
• Approve Master Production Records.
• Review and approve all process start up activities and provide oversight for audit-related activities.
• Contribute to continuous improvement via project teams.

Skills

Communication

Decision making

Teamwork

GMP knowledge

Education

BS in chemistry, engineering, science, or equivalent

Tools

SAP

TrackWise

Job description

Evonik Corporation in Lafayette, Indiana seeks a QA Compliance professional to ensure daily manufacturing operations meet cGMP and ISO 9001 requirements. The role mentors the Assistant QA representative and supports audits and regulatory readiness.

Ideal candidates hold a BS in chemistry, engineering, or related field with 3–5 years GMP experience, demonstrating change controls, deviation investigations, and validation documentation. Strong communication and 24/7 coverage readiness are essential.