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 

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.

Additional Information :

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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time