Biotech QA Release & Compliance Specialist

Boehringer Ingelheim GmbH; Athens (GA); On-site; USD 70,000 - 90,000; Full time

Job summary

Boehringer Ingelheim is seeking a QA Release Specialist in Athens, GA to review batch records, COAs, and compliance with USDA/FDA/cGMP standards. This role supports manufacturing across internal and external CMOs and ensures specifications are met before release.

The ideal candidate holds a BS or MS in a scientific field with 2 years of related experience, strong attention to detail, excellent written and verbal communication, and proficiency with SAP, IDEA for CON, and Microsoft Office.

Qualifications

• BS or MS in a relevant scientific discipline with 2 years of related experience required; or MS in a relevant field.
• Requires ability to utilize computer programs such as SAP, IDEA for CON, Learning One Source and other electronic applications.
• Exceptional written and verbal communication skills and strong regulatory knowledge for USDA/FDA/cGMP compliance.

Responsibilities

• Review and approve batch records for compliance with SOPs.
• Review Certificates of Analysis and Certificates of Conformance for batch release.
• Perform SAP movement transactions and release decisions for batches.
• Assist with audits/inspections and support regulatory compliance activities.

Skills

Attention to detail

Written & verbal communication

Regulatory knowledge

Decision making

Education

Bachelor's degree in Life Sciences

Master's degree in Life Sciences

Tools

SAP

IDEA for CON

Microsoft Office

Learning One Source

Job description

Boehringer Ingelheim is seeking a QA Release Specialist in Athens, GA to review batch records, COAs, and compliance with USDA/FDA/cGMP standards. This role supports manufacturing across internal and external CMOs and ensures specifications are met before release.

The ideal candidate holds a BS or MS in a scientific field with 2 years of related experience, strong attention to detail, excellent written and verbal communication, and proficiency with SAP, IDEA for CON, and Microsoft Office.