GMP Documentation & Compliance Specialist

AbbVie Inc.; Missouri; On-site; USD 54,000 - 73,000; Full time

Job summary

AbbVie Inc. is seeking a document control professional to manage GMP-compliant documentation for manufacturing. The role emphasizes accuracy, traceability, and cross-functional collaboration with Manufacturing, QA, Planning, and Supply Chain teams. Proficiency in SAP and eDMS is required.

The position supports issuance of batch records, change controls, and related records, ensuring only approved documents are used in manufacturing and that all records remain compliant and auditable.

Qualifications

• Knowledge of GMP documentation practices.
• Strong attention to detail and accuracy.
• Experience with document control and records management.
• Ability to work with Manufacturing, QA, Planning, and Supply Chain teams.
• Proficiency with SAP and document management systems.
• Strong organizational and compliance mindset.

Responsibilities

• Issue production batch records, worksheets, packaging records, and related controlled documents using approved systems and current effective versions.
• Assign and verify batch numbers, process order numbers, and document revisions prior to issuance.
• Ensure only current, approved documentation is issued for manufacturing use.
• Print, prepare, stamp, and control manufacturing documentation according to site procedures.
• Maintain document accountability, issuance logs, and controlled records.
• Support Manufacturing, Planning, Quality Assurance, and Process Sciences by preparing records for scheduled production activities.
• Process requests for additional pages, replacement documentation, and document revisions while maintaining traceability.
• Verify issued documentation is complete, legible, accurate, and attributable to the correct batch.
• Maintain compliance with GMP, GDP, Data Integrity, and document control requirements.
• Support investigations, audits, inspections, and document retrieval requests as required.

Skills

GMP knowledge

Attention to detail

Documentation & records management

Tools

SAP

eDMS/Vault

POMSnet/MES

Job description

AbbVie Inc. is seeking a document control professional to manage GMP-compliant documentation for manufacturing. The role emphasizes accuracy, traceability, and cross-functional collaboration with Manufacturing, QA, Planning, and Supply Chain teams. Proficiency in SAP and eDMS is required.

The position supports issuance of batch records, change controls, and related records, ensuring only approved documents are used in manufacturing and that all records remain compliant and auditable.