Senior QA Release Specialist – Compliance & Batch Release

Boehringer Ingelheim GmbH

Northern (KY)

Hybrid

USD 110,000 - 160,000

Full time

43 hours ago

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Job summary

Boehringer Ingelheim USA in Kentucky seeks a QA Release professional to review batch records, certificates, and APHIS/MBPS documents, ensuring compliance with USDA, FDA and cGMP standards. You will act as a deputy to the Qualified Person, providing SME support for QA Release, change controls, CAPAs, deviations, and serial/lots release, with responsibilities spanning SAP movements and export documentation.

Qualifications include advanced degree in science and several years of regulatory release

Qualifications

BS degree in a relevant scientific discipline with experience in batch release and regulatory compliance.
MS degree in a relevant scientific discipline with 3+ years of relevant experience.
PhD in a relevant scientific discipline is required for this position.

Responsibilities

Review and approve batch records and Certificates of Analysis/Conformance for batch release.
Perform review and approvals of change controls as a subject matter expert (SME) in QA Release.
Lead investigations and deviations, and participate in CAPA closure.
Support audits/inspections as SME for QA Release strategies and regulatory readiness.
Utilize SAP for product movement and release decisions.