Documentation and Compliance Specialist
Role Overview
• 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.)
Key Skills for This Role
Full Job Posting
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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.
- 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
- https://www.abbvie.com/join-us/reasonable-accommodations.html
About AbbVie
AbbVie is a global biopharmaceutical company specializing in immunology, oncology, neuroscience, and eye care. The company develops and markets treatments including Humira, Skyrizi, and Rinvoq.
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