Batch Disposition Specialist — Quality & Compliance

Boehringer Ingelheim Pharmaceuticals, Inc.; Columbus (OH); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Boehringer Ingelheim Pharmaceuticals, Inc. in Columbus, OH is seeking a Specialist IV, Batch Disposition to ensure batches from CMOs and BI OPUs meet marketing authorization and cGMP requirements.

The role emphasizes accuracy, timely escalation, and collaboration with 3PQM to safeguard the supply chain. Responsibilities include batch record review, final disposition decisions, and interaction with CMOs to resolve non-standard events.

Qualifications

• BS/BA in Chemistry, Pharma or related science with minimum five (5) years’ experience in compliance, QA, or manufacturing document review.
• Diploma with minimum seven (7) years’ pharma experience in compliance, QA, or manufacturing document review.
• Registered Pharmacist preferred.

Responsibilities

• Independently performs batch record review and final disposition ensuring compliance with specifications, cGMPs, and policies.
• Has authority to make batch disposition decisions (approve to distribute or reject) and resolves non-standard events with CMOs.
• Tracks Quality Metric data including batch disposition rate and data trends for process improvements.
• Escalates unresolved non-compliance concerns to 3PQM and management to prevent supply chain disruption.
• Ensures correct documentation is provided Right First Time and obtains commitments from CMOs prior to disposition.
• Completes SAP transactions related to batch disposition and supports cross-functional teams.

Skills

batch disposition

cGMP knowledge

QA documentation

SAP transactions

quality metrics

cross-functional teamwork

Education

BS/BA in Chemistry

Diploma with 7+ years pharma experience

Registered Pharmacist preferred

Tools

SAP

Job description

Boehringer Ingelheim Pharmaceuticals, Inc. in Columbus, OH is seeking a Specialist IV, Batch Disposition to ensure batches from CMOs and BI OPUs meet marketing authorization and cGMP requirements.

The role emphasizes accuracy, timely escalation, and collaboration with 3PQM to safeguard the supply chain. Responsibilities include batch record review, final disposition decisions, and interaction with CMOs to resolve non-standard events.