Senior QA Release Specialist: Regulatory Docs & Compliance

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

Job summary

Boehringer Ingelheim is seeking a QA Release professional to review batch records, ensure regulatory compliance, and support release documentation for biologics. You will act as a deputy to the Qualified Person and collaborate with QA, manufacturing, and regulatory teams.

Responsibilities include review of COAs, change controls, deviations, CAPAs, and SAP movements. The role requires hands-on expertise in regulatory requirements and excellent documentation skills.

Qualifications

• Requires BS/MS/PhD in a relevant scientific discipline with 3–5 years of experience.
• Experience with regulatory compliance and documentation in biopharma.
• Familiarity with USDA/FDA/cGMP requirements.

Responsibilities

• Review and approve batch documentation for compliance with SOPs and standards.
• Approve Certificates of Analysis/Conformance for batch release.
• Review change controls and manage actions to closure.
• Support APHIS forms for USDA serial releases and international permits.
• Participate in internal and external audits and inspections.
• Assist with training within the department and project execution.

Skills

Documentation review

QA release

Change control

Audits/inspections

Regulatory knowledge

SAP

Cross-functional collaboration

Education

Bachelor's degree in a relevant scientific discipline

Master's 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, ensure regulatory compliance, and support release documentation for biologics. You will act as a deputy to the Qualified Person and collaborate with QA, manufacturing, and regulatory teams.

Responsibilities include review of COAs, change controls, deviations, CAPAs, and SAP movements. The role requires hands-on expertise in regulatory requirements and excellent documentation skills.