Global QA Release Specialist - Compliance & Documentation

Boehringer Ingelheim GmbH; Athens (GA); On-site; USD 76,000 - 105,000; Full time

Job summary

Boehringer Ingelheim is seeking a QA Release specialist in Georgia to review and approve batch records and release materials in accordance with USDA, FDA, and cGMP standards. The role supports manufacturing from multiple CMOs and collaborates across the Quality and Compliance unit.

Responsibilities include document review, change controls, CAPAs, and SAP-based release activities, with opportunities to contribute to audits and project initiatives within a global organization.

Qualifications

• Requires BS or MS in a relevant scientific discipline.
• Experience with regulatory requirements for production and distribution of regulated biological articles.
• Excellent written and verbal communication skills.

Responsibilities

• Review and approve batch record documentation for compliance with cGMP and SOPs.
• Review Certificates of Analysis and Certificates of Conformance for batch release.
• Perform SAP movement transactions and release decisions for batches.
• Lead/change controls as SME in QA Release and coordinate with cross-functional teams.
• Initiate deviations in electronic systems and participate in deviation investigations.
• Support internal/external audits and act as SME during inspections.

Skills

Documentation control

SOP compliance

Written communication

Verbal communication

USDA/FDA regulations

Attention to detail

SAP

IDEA for CON

Education

Bachelor's degree in a relevant scientific discipline

Master's degree in a relevant scientific discipline

Tools

SAP

IDEA for CON

Learning One Source

Job description

Boehringer Ingelheim is seeking a QA Release specialist in Georgia to review and approve batch records and release materials in accordance with USDA, FDA, and cGMP standards. The role supports manufacturing from multiple CMOs and collaborates across the Quality and Compliance unit.

Responsibilities include document review, change controls, CAPAs, and SAP-based release activities, with opportunities to contribute to audits and project initiatives within a global organization.