At a Glance
- Tasks: Manage and issue essential production documents while ensuring compliance with industry standards.
- Company: Join AbbVie, a leader in innovative medicines and health solutions.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic work environment with a commitment to innovation and community service.
- Why this job: Make a real difference in healthcare by supporting vital manufacturing processes.
- Qualifications: Knowledge of GMP practices and strong attention to detail required.
The predicted salary is between 62100 - 75900 $ per year.
- Company Description
- About Abb Vie
Abb Vie'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 Abb Vie, please visit us at Follow @abbvie on Linked In, ( Facebook, Instagram ( , X ( and You Tube.
- 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 (e DMS/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
Abb Vie 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
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Documentation and Compliance Specialist in Westport employer: AbbVie
AbbVie is an exceptional employer that fosters a high-trust and inclusive culture, as evidenced by our Great Place to Work® Certification. Located in Quebec, we offer a vibrant work environment where employees can thrive through mentorship and professional development opportunities, all while contributing to innovative healthcare solutions that make a meaningful impact on people's lives. Join us to unlock a world of possibilities and be part of a team dedicated to transforming lives and addressing critical health challenges.
