Documentation and Compliance Specialist

• 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. (The procedures establish controlled-document accountability and retention activities.) 

Typical Systems Used

• SAP
• Electronic Document Management Systems (eDMS/Vault)
• POMSnet / MES (where applicable)
• Batch record tracking and issuance tools 

• 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.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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