QA Batch Release Specialist: Compliance & Documentation

Boehringer Ingelheim; Gainesville (GA); On-site; USD 90,000 - 120,000; Full time

Job summary

Boehringer Ingelheim in the United States seeks a QA Release specialist to review batch records, release documentation, and APHIS forms. You will ensure compliance with USDA/FDA and cGMP standards throughout the manufacturing lifecycle.

This role supports audits, CAPA processes, and change controls within the Quality and Compliance unit, interacting with SAP and related systems to ensure accurate product releases.

Qualifications

• BS or MS in a relevant scientific discipline with 2+ years of experience
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Responsibilities

• Documentation Review/Approvals: prepare batch record documentation and review for compliance to Good Documentation Practices and SOPs
• Resolves issues found during documentation review; major issues defined by SOP
• Reviews and approves Certificates of Analysis/Conformance for batch release
• Reviews APHIS Form 2008s and MBPS/CBRs for USDA releases
• Performs change control reviews as SME in QA Release
• Initiates deviations when non-conformances are detected
• Performs movement transactions and usage decisions in SAP for batch release
• Participates in project teams and training within the department
• Supports audits/inspections as SME during strategy rooms

Skills

Attention to detail

Written and verbal communication

Regulatory understanding

Education

Bachelor's/MS in a relevant scientific discipline

Tools

SAP

IDEA for CON

Learning One Source

Microsoft Office

Job description

Boehringer Ingelheim in the United States seeks a QA Release specialist to review batch records, release documentation, and APHIS forms. You will ensure compliance with USDA/FDA and cGMP standards throughout the manufacturing lifecycle.

This role supports audits, CAPA processes, and change controls within the Quality and Compliance unit, interacting with SAP and related systems to ensure accurate product releases.