QA Release Specialist: Compliance & Batch Documentation

Biopharma Careers; Kentucky; On-site; USD 65,000 - 90,000; Full time

Job summary

Boehringer Ingelheim is seeking a QA Documentation Reviewer for batch record review and release. The role ensures all specifications are met in line with USDA, FDA, and cGMP standards and supports product releases from internal and external sources.

You will review and approve Certificates of Analysis, APHIS forms, and international permits, while handling deviations, CAPAs, and change controls within the QA Release domain. Strong regulatory knowledge and SAP experience are essential.

Qualifications

• Bachelor's or Master’s degree in a scientific field.
• Experience with regulatory requirements for production and distribution.
• Ability to use SAP and other electronic systems effectively.
• Strong written and verbal communication skills.
• Attention to detail and the ability to interpret specifications.

Responsibilities

• Prepare batch record documentation and review for compliance with cGMP and SOPs.
• Review Certificates of Analysis/Conformance for batch release.
• Approve APHIS Form 2008s and permits for regulatory submissions.
• Lead change controls as QA Release SME and close action items.
• Initiate deviations and participate in deviation investigations.
• Perform SAP movements and usage decisions for batch releases.
• Participate in audits and provide SME support during inspections.
• Assist with training plans and project initiatives within QA.

Skills

Attention to detail

Written communication

Verbal communication

Regulatory knowledge

Decision making

Education

BS or MS in a relevant scientific discipline

Tools

SAP

IDEA for CON

Learning One Source

Job description

Boehringer Ingelheim is seeking a QA Documentation Reviewer for batch record review and release. The role ensures all specifications are met in line with USDA, FDA, and cGMP standards and supports product releases from internal and external sources.

You will review and approve Certificates of Analysis, APHIS forms, and international permits, while handling deviations, CAPAs, and change controls within the QA Release domain. Strong regulatory knowledge and SAP experience are essential.