QA Release Specialist: Documentation & Compliance Expert

Boehringer Ingelheim; Gainesville (GA); On-site; USD 110,000 - 160,000; Full time

Job summary

Boehringer Ingelheim is seeking a QA Release professional to review batch records, COA/CoC, and APHIS/MBPS documents ensuring compliance with USDA, FDA, and cGMP requirements. The role acts as a deputy to the Qualified Person and supports change controls, deviations, CAPAs, and SAP movements.

You'll work in a global, collaborative biotech environment with training programs and opportunities for leadership in project teams.

Qualifications

• BS degree in a relevant scientific discipline plus five (5) years of relevant experience OR
• MS degree in a relevant scientific discipline plus three (3) years relevant experience OR
• PhD in a relevant scientific discipline is required for this position

Responsibilities

• Documentation Review/Approvals: prepares batch record documentation and performs review for compliance to Good Documentation Practices and against established SOPs/standards
• Change Control: performs review and approvals of change controls as a SME in QA Release for routine change controls
• Deviations/CAPA: initiates deviations in Quality electronic systems when non-conformances are detected during documentation review
• SAP: performs movement transactions in SAP system of product as needed
• Projects: actively participates in project teams as assigned by supervisor
• Training: completes all assigned training by target due dates as assigned by BIVI
• Audits/Inspections: participates in internal and 3rd party audits and serves as SME during inspections
• Quality/Eligibility: ensures compliance with USDA, FDA and cGMP regulatory requirements for production and distribution

Skills

Regulatory compliance

Documentation review

Quality systems

Attention to detail

Decision making

Biology knowledge

Education

BS degree in a relevant scientific discipline

MS degree in a relevant scientific discipline

PhD in a relevant scientific discipline

Tools

SAP

Job description

Boehringer Ingelheim is seeking a QA Release professional to review batch records, COA/CoC, and APHIS/MBPS documents ensuring compliance with USDA, FDA, and cGMP requirements. The role acts as a deputy to the Qualified Person and supports change controls, deviations, CAPAs, and SAP movements.

You'll work in a global, collaborative biotech environment with training programs and opportunities for leadership in project teams.