Biologics QA Release Specialist

Boehringer Ingelheim GmbH; Spring Valley Estates (GA); On-site; USD 75,000 - 105,000; Full time

Job summary

Boehringer Ingelheim GmbH is seeking a Quality Assurance reviewer to ensure batch records and release documentation comply with USDA, FDA and cGMP requirements. The role covers serial releases, APHIS-related forms, and collaboration with QA across production stages.

The position requires a BS or MS in a relevant science and 2+ years of experience, with strong communication and attention to detail. On-site work in Georgia is expected, with involvement in audits and training as needed.

Qualifications

• Requires BS or MS in a relevant scientific field with 2+ years of experience.
• Exceptional written and verbal communication and strong attention to detail.
• Solid understanding of USDA, FDA and cGMP regulations for production releases.

Responsibilities

• Review batch record documentation for compliance with SOPs and documentation standards.
• Approve Certificates of Analysis and Certificates of Conformance for batch release.
• Perform SAP movements and usage decisions; execute second checks prior to batch release.

Skills

Attention to detail

Written and verbal communication

Regulatory awareness

Education

BS degree in relevant scientific discipline

MS degree in relevant scientific discipline

Tools

SAP

IDEA for CON

Microsoft Office

Job description

Boehringer Ingelheim GmbH is seeking a Quality Assurance reviewer to ensure batch records and release documentation comply with USDA, FDA and cGMP requirements. The role covers serial releases, APHIS-related forms, and collaboration with QA across production stages.

The position requires a BS or MS in a relevant science and 2+ years of experience, with strong communication and attention to detail. On-site work in Georgia is expected, with involvement in audits and training as needed.