Biologics QA Release Lead

Boehringer Ingelheim GmbH; Spring Valley Estates (GA); On-site; USD 65,000 - 90,000; Full time

Job summary

Boehringer Ingelheim GmbH in Georgia seeks a QA Documentation Reviewer to ensure batch records meet cGMP and USDA/FDA requirements. The role supports release of starting materials, in-process and finished biological products across the manufacturing network, including CMOs.

Responsibilities include preparing and reviewing batch records, COA, COFC, change controls as SME, deviations/CAPAs, SAP movements, and participation in audits.

Qualifications

• BS degree in a relevant scientific discipline with 2 years experience, or MS degree.
• Proficiency with Microsoft Suite, SAP, IDEA for CON, Learning One Source.
• Strong written and verbal communication; attention to detail.
• Understanding of USDA/EU regulatory requirements for regulated production.

Responsibilities

• Review and approve batch records and Certificates of Analysis.
• Perform change control reviews as SME in QA Release.
• Initiate deviations and participate in CAPA investigations.
• Process SAP movement transactions and batch release decisions.
• Contribute to internal audits and inspection readiness.

Skills

Documentation review

SAP

Regulatory compliance

Attention to detail

Communication skills

Education

Bachelor's degree in a relevant field

Tools

Microsoft Office

SAP

IDEA for CON

Learning One Source

Job description

Boehringer Ingelheim GmbH in Georgia seeks a QA Documentation Reviewer to ensure batch records meet cGMP and USDA/FDA requirements. The role supports release of starting materials, in-process and finished biological products across the manufacturing network, including CMOs.

Responsibilities include preparing and reviewing batch records, COA, COFC, change controls as SME, deviations/CAPAs, SAP movements, and participation in audits.